Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Metformin Hydrochloride Extended-release Tablets USP
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk
Irinotecan HCL Injection
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk
Aripiprazole Tablets
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
metFORMIN HCL ER 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
metFORMIN HCL ER USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk
Walker Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk
Walker Emulsions Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk
Soft Whisper by Powerstick Dandruff Shampoo
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended - Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Handese Advanced Instant Hand Sanitizer
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
Class II · Moderate risk
Unasyn (ampicillin sodium/sulbacatam)
Presence of Particulate Matter: particulate matter identified after reconstitution.
Class II · Moderate risk
Gaviscon Liquid Antacid Extra Strength
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Regular Strength Liquid Antacid Cool Mint
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Regular Strength Liquid Antacid Cool Mint
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.