An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).
Recall Database
Drug & Medical Product Contamination Recalls
This hub is the contamination and sterility side of the drug and medical-product feed: 300 records where the recall points to an impurity, a nitrosamine or other chemical contaminant, a non-sterility finding, or a manufacturing-quality failure. Of these, 291 are FDA records and 9 are from the CPSC. Alongside the FDA drug and medical-device records, a small number of CPSC consumer-product contamination recalls — mold, bacteria, and similar findings — are grouped here because contamination is the shared hazard class.
It sits alongside Drug & Medication Defect. Use this one when the issue is what got into the product — an impurity, a contaminant, a broken sterile barrier — rather than a dosage or labeling error. Many of these records also carry a secondary drug-and-device tag, because the same notice often touches both the product and its manufacture.
The notices span 2023–2026, heaviest in 2026. Every row links to the FDA or CPSC record with the affected lots and the firm's corrective action.
How this hub is built. This page groups the 300 recall records that 411 Press classifies as Drug & Medical Product Contamination. Each record gets one primary hazard from a fixed, published rule set (taxonomy version 2026-07-28.C2.2 — this stamp marks when the classification rules last changed, not how current the recall data is; data currency is stated below). A record can carry secondary hazard tags but appears on only one hub. Regulators in this hub: FDA (291), CPSC (9). These notices were published 2023–2026. This is not an all-time archive — it is the current dataset, drawn from CPSC, FDA, and NHTSA notices and refreshed as new notices are ingested from the agency feeds, so it grows over time. A note on counting. This hub counts RECORDS, not recall events. The agencies package recalls differently — NHTSA issues one record per safety campaign, the CPSC one per recall, the FDA one per affected product line — so an FDA-heavy hub carries more product-line records per underlying recall than a CPSC or NHTSA one. Records here are grouped by hazard; the brand hubs, which rank companies, count by event instead. Every row links to the original agency notice. The agency's record is the authority; the hazard grouping is ours. For a small number of records the agency feed's own hazard text did not pass our integrity check; those rows read "See the agency notice for the hazard description" and link straight to the source, rather than show a summary we can't stand behind.
2026 (199)
- FDAClass II
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
- FDAClass II
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
- FDAClass II
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
- FDAClass II
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
- FDAClass II
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
- FDAClass II
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- FDAClass III
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- FDAClass III
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- FDAClass II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- FDAClass II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- FDAClass II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- FDAClass II
Methohexital Sodium
Failed Impurities/Degradation Specifications
- FDAClass I
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
- FDAClass II
DULOXETINE D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- FDAClass II
Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
- FDAClass II
Methohexital Sodium for Injection
Failed Impurities/Degradation Specifications
- FDAClass II
Chlorthalidone Tablets
Failed Dissolution Specifications
- FDAClass II
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
- FDAClass I
Gas-X Extra Strength
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- FDAClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- FDAClass II
Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
- FDAClass II
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy
Presence of Foreign Substance.
- FDAClass II
Corlanor (ivabradine) tablets
Presence of Foreign Substance.
- FDAClass III
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- FDAClass III
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
- FDAClass III
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
- FDAClass I
BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
- FDAClass II
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- FDAClass II
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
- FDAClass II
GSMS Incorporated
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
- FDAClass II
TopCare health
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
TopCare health
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
MARKET BASKET ANTACID Calcium Carbonate 1000 mg
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
KIRKLAND Signature
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
HyVee
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
HyVee
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
Harris Teeter
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
HALEON CALCIUM CARBONATE TUMS ANTACID
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
HALEON CALCIUM CARBONATE TUMS ANTACID
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
H.E.B Extra Strength Calcium Carbonate Antacid Tablets
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
GOODSENSE Ultra Strength
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
GOODSENSE Extra Strength
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
Good Neighbor Pharmacy
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
Good Neighbor Pharmacy
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
FAMILY WELLNESS
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
FAMILY WELLNESS
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
Extra strength Antacid Calcium Carbonate 750 mg
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
EQUALINE ultra strength
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
EQUALINE extra strength
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
DISCOUNT drug mart
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
CAREone
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
CAREone
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
24/7 life BY 7-ELEVEN
Presence of foreign substance: small metallic particles in chewable tablets.
- FDAClass II
Niacin Extended-release Tablets
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- FDAClass II
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- FDAClass II
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc
Microbial contamination of sterile products
- FDAClass I
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- FDAClass III
Epinephrine Injection
Failed Impurities/Degradations Specifications
- FDAClass III
Nicotine Transdermal System Patch
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- FDAClass II
Duloxetine DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- FDAClass I
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
- FDAClass I
DOXOrubin Hydrochloride Liposome injection
Presence of Particulate matter: Particulate matter identified as glass.
- FDAClass II
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- FDAClass III
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd
Failed Impurities/Degradation Specifications
- FDAClass II
Vitamin B-Complex
Presence of a Foreign Substance; black particles observed in liquid
- FDAClass III
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- FDAClass III
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- FDAClass II
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- FDAClass II
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- FDAClass I
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B
Presence of Particulate Matter.
- FDAClass III
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- FDAClass III
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- FDAClass II
Ascend Laboratories
Failed Dissolution Specifications
- FDAClass I
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
- FDAClass II
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
- FDAClass III
Primidone Tablets USP
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- FDAClass II
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- FDAClass II
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl
Lack of assurance of Sterility: potential product contamination
- FDAClass II
BD PurPrep
Lack of assurance of Sterility: potential product contamination
- FDAClass II
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
Contamination to in-vitro diagnostic test may result in false positives.
- FDAClass II
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- FDAClass II
NAPROXEN ORAL SUSPENSION
Chemical contamination; presence of lead and lithium above specification
- FDAClass II
Codman CerebroFlo EVD Catheter with Endexo Technology
Out-of-specification endotoxin result that did not meet the acceptance criteria.
- FDAClass II
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
- FDAClass I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
- FDAClass II
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
- FDAClass II
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- FDAClass II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- FDAClass II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- FDAClass II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- FDAClass II
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
- FDAClass II
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm
Potential for product to contain foreign matter, confirmed to be inspect fragments.
- FDAClass II
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
- FDAClass I
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Namic Angiographic Manifold
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Namic Angiographic Manifold
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Namic Angiographic Manifold
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Medline medical convenience kits
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
1
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
1
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass II
GE Healthcare Omnipaque (iohexol) Injection
Presence of particulate matter
- FDAClass II
GE Healthcare Omnipaque (iohexol) Injection
Presence of particulate matter
- FDAClass II
Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- FDAClass II
Medline Neuro Sponges, various dimensions, labeled as: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Medline and Centurion medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Centurion medical procedure kits
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- FDAClass II
Cytal Wound Matrix 2-Layer 7x10 cm
Increased rate of out-of-specification endotoxin results.
- FDAClass II
Cytal Wound Matrix 2-Layer 5x5 cm
Increased rate of out-of-specification endotoxin results.
- FDAClass II
Cytal Wound Matrix 2-Layer 10x15 cm
Increased rate of out-of-specification endotoxin results.
- FDAClass II
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
- FDAClass II
Xanax XR
Failed Dissolution Specifications
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDAClass II
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- FDAClass II
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl
Chemical contamination: Presence of benzene
- FDAClass II
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl
Chemical contamination: Presence of benzene
- FDAClass II
HydroPeptide CLEAR ALLIANCE SERUM
Chemical contamination: Presence of benzene
- FDAClass II
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl
Chemical contamination: Presence of benzene
- FDAClass II
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- FDAClass I
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
- FDAClass II
Amnesteem (Isotretinoin) Capsules
Failed Dissolution Specifications
- FDAClass II
Semaglutide
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- FDAClass II
Semaglutide
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- FDAClass II
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- FDAClass II
Adbry
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
- FDAClass II
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
- FDAClass III
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
- FDAClass II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
- FDAClass II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
- FDAClass II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
- FDAClass II
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
- FDAClass II
Sodium Iodide (I-131) Solution
Presence of Particulate Matter: Due to production issues
- FDAClass II
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
- FDAClass II
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32
Presence of Foreign substance - potential presence of metal particulate matter
- CPSCInfo
Angry Orange Enzyme Stain Removers
The recalled products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems, external medical devices, or underlying lung conditions who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by bacteria.
- FDAClass II
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- FDAClass II
Furosemide Tablets
Presence of Foreign Substance
- FDAClass II
Lanreotide Injection
Presence of Particulate Matter.
2025 (95)
- FDAClass II
Rosuvastatin Tablets
Out of specification for dissolution.
- FDAClass III
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- FDAClass II
TYLENOL a) 500 MG
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
TUMS a) Assorted
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Swan, White Clear Alcohol, 50%, 16oz, 12 count
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Petroleum jelly: a) Vaseline Petroleum Jelly
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
PEPTO BISMOL 32CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
PEPCID COMPLETE - 25CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
NYQUIL COLD & FLU -32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
MOTRIN 2'S DISP.- 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
LIQUID DAYQUIL 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Halls Cough Drops a) BAGS
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
EXCEDRIN MIGRAINE 2'S- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
EXCEDRIN 2'S DISP.- 30 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Deodorant: a) Axe
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
DAYQUIL COLD & FLU, 32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Claritin, 20 Count, UPC: 655708016305
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Benadryl, 25'S 2PK Box, UPC 815556020316
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Bayer 2Pk- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Alka Seltzer
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Aleve 1's, 60 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Sterile Water for Irrigation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- FDAClass II
Wegovy (semaglutide) Injection
Presence of Particulate Matter: Hair was found in a prefilled syringe
- FDAClass II
Wegovy (semaglutide) Injection
Presence of Particulate Matter: Hair was found in a prefilled syringe
- FDAClass II
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection
Presence of particulate matter - Glass like particles.
- FDAClass II
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
- FDAClass II
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
- FDAClass III
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- FDAClass I
MR
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
- FDAClass III
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz
Failed Impurities/Degradation Specifications
- FDAClass II
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension
Presence of particulate matter: potential presence of metal particulates in the product.
- FDAClass II
Merck Emend (aprepitant) for oral suspension
Presence of particulate matter: potential presence of metal particulates in the product.
- FDAClass I
ReBoost Nasal Spray, 0.68 fl
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
- FDAClass I
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
- FDAClass II
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- FDAClass III
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- FDAClass II
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA
Presence of Foreign Tablets/Capsules
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- FDAClass II
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- FDAClass III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- FDAClass III
Nebivolol Tablets
Cross Contamination with Other Products
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- FDAClass II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- FDAClass II
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- FDAClass II
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- FDAClass I
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- FDAClass II
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- FDAClass II
Agebox iKids-Growth (Night Formula)
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
- FDAClass II
Agebox iKids-Growth (Day Formula) capsules
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
- FDAClass II
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- FDAClass II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- FDAClass II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- FDAClass II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- FDAClass II
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
- FDAClass I
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
- FDAClass II
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
CGMP Deviations: Potential presence of metal particulate matter
- FDAClass II
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
- FDAClass II
Testosterone 62.5 MG
CGMP Deviations: Potential presence of metal particulate matter
- FDAClass II
Testosterone 50MG
CGMP Deviations: Potential presence of metal particulate matter
- FDAClass III
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- FDAClass III
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- FDAClass I
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
- FDAClass II
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
- FDAClass II
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
- FDAClass II
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- FDAClass II
TESTO-100 CIII (testosterone 100 mg)
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
- FDAClass II
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
San-E-Foam, Alcohol 67%, 1000 mL
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
Renew Skin Repair Cream
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
Renew PeriProtect
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
PeriGuard Ointment
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
McKesson Skin Protectant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
Lantiseptic
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
Lantiseptic
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
KleenFoam Antimicrobial Foam Soap
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
Hand-E-Foam
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
GelRite Instant Hand Sanitizer
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
DermaFungal
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
DermaCerin
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- FDAClass II
4-N-1 Skin Protectant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- CPSCWarning
U and U+ Window Air Conditioners
Pooled water in the air conditioners can fail to drain quickly enough, which can lead to mold growth. Mold exposure poses risks of respiratory issues or other infections to some consumers.
- CPSCInfo
Woolite Delicates detergent in 50-fluid-ounce bottles
The recalled products can contain Pseudomonas species bacteria, including Pseudomonas oleovorans, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to the bacteria face a risk of serious infection that may require medical treatment. The bacteria can enter the body through the eyes or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.
2024 (4)
- CPSCInfo
Hallmark Keepsake Christmas Tree Ornaments featuring the Cad Bane character from Star Wars: The Book of Boba Fett
The brown paint on the exterior of the recalled Christmas tree ornaments did not fully dry before packaging, causing mold to grow on the exterior surface of the ornament, posing risk of respiratory issues to consumers due to mold exposure.
- CPSCInfo
FURminator deShedding Ultra Premium Dog Conditioner (1 Gallon)
The recalled conditioner can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.
- CPSCWarning
Project Watson Eyelid Wipes for Dogs
When the recalled dog eyelid wipes are opened and in use, bacteria and fungi, which are organisms found widely in the environment, soil, and water, can be introduced and grow in the container, posing a risk of serious infection to people with weakened immune systems. Individuals with wounds may also be at higher risk of infection. People with healthy immune systems are not typically affected.
- CPSCInfo
Purefog High Density Natural Fog Juice Liquids
The recalled fog liquid can expire sooner than the expiration date listed on the product. This can pose a risk of respiratory or other infections in individuals with compromised immune systems, damaged lungs or an allergy to mold.
2023 (2)
- CPSCWarning
Capri Blue Pet Sprays and Shampoos
The recalled pet products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.
- CPSCInfo
Novaform ComfortGrande 14-inch and Novaform DreamAway 8-inch Mattresses
The mattresses could have been exposed to water during the manufacturing process allowing mold to develop and posing a health risk to individuals with compromised immune systems, damaged lungs or an allergy to mold.