Warning
Class II
Swan, White Clear Alcohol, 50%, 16oz, 12 count
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
FDA Recalls
Page 36 of 40 · 1,986 total recalls
Recalls — Page 36
Warning
Class II
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
Warning
Class II
TUMS a) Assorted
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
Warning
Class II
TYLENOL a) 500 MG
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
Info
Class III
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date...
Haleon US Holdings LLC
Warning
Class II
Australian Greenlip Abalone, Frozen, 9 pieces, Net Wt
Potential Listeria Monocytogenes contamination
Southern Rocklobster LTD USA
Warning
Class II
Sterile Water for Irrigation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Baxter Healthcare Corporation
Critical
Class I
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt
CGMP Deviations: product found to contain lead.
HANDELNINE GLOBAL LLC
Info
Class III
Willy Pete's Chocolates brand Almond Despair
Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.
Willy Pete's Chocolate Company LLC
Critical
Class I
Atwater's, Holiday Cookie Tin, 19.65 ounces, Round metal tin with a window lid
Undeclared tree nut allergens: almonds, pecans, and walnuts.
One Roof LLC
Critical
Class I
Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based, net wt
undeclared hazelnut.
Fran's Chocolates Ltd
Critical
Class I
Gregory's Foods Bag Full of Cookies, White Chocolate Macadamia Nut, frozen cookie dough
Undeclared peanuts.
Gregory's Foods
Warning
Class II
Wegovy (semaglutide) Injection
Presence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc.
Warning
Class II
Wegovy (semaglutide) Injection
Presence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc.
Warning
Class II
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone)
Failed Disintegration Specifications: above the time expected.
Sato Pharmaceutical Co.
Critical
Class I
Troemner Family Farm Pfeffernusse Cookies, 6oz and 12oz bags
undeclared soy, wheat, milk
Troemner Farm
Info
Class III
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of...
Zydus Pharmaceuticals (USA) Inc
Warning
Warning
Warning
Class II
Mini Gaceniga Authentic Cuban Loaf Cake Raisins
Undeclared colors FD&C Yellow #5
CATAO MARKET LLC
Warning
Class II
Mini Gaceniga Authentic Cuban Loaf Cake Classic
Undeclared colors FD&C Yellow #5
CATAO MARKET LLC
Warning
Class II
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
Imprimis NJOF
Warning
Class II
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Imprimis NJOF
Warning
Class 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.
Imprimis NJOF
Warning
Class II
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v)
Lack of Assurance of Sterlity
CareFusion 213
Info
Info
Warning
Class II
Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Rovira Biscuit Corporation
Info
Class III
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited
Info
Class III
Publix Rice & Pigeon Peas, Net Wt 32 oz (2lb), Plastic tray with clear lid, black film, and a pre-printed label
Undeclared Allergen (Soy)
ASK Foods Inc
Warning
Class II
Qunol
Mold contamination detected for raw material lots that were produced in July and used in finished goods.
QUTEN RESEARCH INSTITIUTE LLC
Warning
Class II
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx
Warning
Class II
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx
Info
Class III
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz
Failed Impurities/Degradation Specifications
NOVADOZ PHARMACEUTICALS LLC
Critical
Class I
MR
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
StuffbyNainax
Warning
Class II
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL)
Foreign material
WhiteWave - Louisville Pilot Plant
Warning
Class II
Sapori Amaretti Almonds 175 g Cookies
Contains elevated levels of hydrocyanic acid
D. Coluccio & Sons Inc.
Warning
Class II
1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6
Undeclared soy lecithin
House Of Flavors
Warning
Class II
2248 Banana Pudding Ice Cream, 3 GAL, UPC 7 65265 81237 8
Undeclared soy lecithin
House Of Flavors
Critical
Class 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...
Medinatura New Mexico