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: 226 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, 210 are FDA records and 16 are from the CPSC.
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 through 2026, concentrated in 2025 and 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 226 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); a record can carry secondary hazard tags but appears on only one hub. Regulators in this hub: FDA (210), CPSC (16). 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 captured through late May 2026 (CPSC and NHTSA refreshed May 27, FDA May 28, 2026), and it grows as new notices are ingested. Every row links to the original agency notice. The agency's record is the authority; the hazard grouping is ours.
2026 (121)
- CPSCCritical
Analemma Water Bottles
The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.
- 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 II
Ascend Laboratories
Failed Dissolution Specifications
- FDAClass II
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- FDAClass II
BD PurPrep
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
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
Codman CerebroFlo EVD Catheter with Endexo Technology.
Out-of-specification endotoxin result that did not meet the acceptance criteria.
- FDAClass II
Claravis (isotretinoin capsule
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
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. Catalog Number: 1050030.
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
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDAClass I
Namic Preceptor 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
Namic Angiographic Manifold
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
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
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
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
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
Buprenorphine Hydrochloride
Presence of particulate matter: identified as Buprenorphine free base
- 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
Chemical contamination: Presence of benzene
- FDAClass II
SLMD Benzoyl Peroxide Acne Lotion
Chemical contamination: Presence of benzene
- FDAClass II
HydroPeptide CLEAR ALLIANCE SERUM
Chemical contamination: Presence of benzene
- FDAClass II
FHF Farmhouse Fresh
Chemical contamination: Presence of benzene
- 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
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
Testosterone
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
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
Presence of Foreign substance - potential presence of metal particulate matter
- FDAClass II
ESTRADIOL
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 (93)
- FDAClass II
Rosuvastatin Tablets
Out of specification for dissolution.
- FDAClass III
Fluocinolone Acetonide Solution Topical Solution USP
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
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
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Personal Care
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
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
LIQUID NYQUIL a) regular
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
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Claritin
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
CHILDREN NYQUIL
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Carmex a) jar
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- FDAClass II
Benadryl
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
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
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 I
ReBoost Nasal Spray
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
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
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
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 (4 fl.
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 (34 fl.
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
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
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
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 (6)
- 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
Allen + Roth-branded Lighted Bathroom Mirrors
The mirrors' glass can detach from the wall attachment base and fall, posing injury and laceration hazards.
- 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.
- CPSCInfo
Snow globes (Little Wanderer)
The snow globes can crack or fracture, posing a laceration hazard.
2023 (6)
- CPSCWarning
Wet & Forget "Xtreme Reach" Outdoor Rapid Application Moss, Mold, Mildew & Algae Stain Remover with Hose End Nozzle
The hose end nozzle clip can dislodge and allow the cleaning solution to spray on users, posing a risk of skin and eye irritation and other injuries.
- CPSCInfo
MI 1615 and 1617 Sliding Glass Doors; Window World 4000 Series and 8000 Series Sliding Glass Doors
The glass can separate from the frame during hurricane conditions which can pose a serious injury hazard.
- 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.
- CPSCWarning
Glass Doorknobs
The recalled glass doorknobs can crack and separate from the doorknob assembly, posing a laceration hazard to consumers.
- CPSCInfo
Carboys
The glass can break due to improper cooling processes, posing a laceration hazard to consumers.