Class II · Moderate risk
metFORMIN HCL ER 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA Drug Recalls
832 recalls, newest first
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 III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
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.
Class II · Moderate risk
oxyTOCIN 30 Units/500 mL
Subpotent drug - Product did not contain drug.
Class II · Moderate risk
Lisinopril Tablets
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk
Duavee (conjugated estrogens/bazedoxifene)
Failed Dissolution Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/ Degradation Specifications