Class II · Moderate risk Terminated
Nystatin Cream
Reason Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Nystatin Cream
Reason Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class I · High risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Reason Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class II · Moderate risk Terminated
metFORMIN HCL ER 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
metFORMIN HCL ER USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason 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 Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason 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 Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason 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 Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Reason Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk Terminated
Walker Hand Sanitizer
Reason 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 Terminated
Walker Emulsions Hand Sanitizer
Reason 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 Terminated
Soft Whisper by Powerstick Dandruff Shampoo
Reason cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended - Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Handese Advanced Instant Hand Sanitizer
Reason Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
Class II · Moderate risk Terminated
Unasyn
Reason Presence of Particulate Matter: particulate matter identified after reconstitution.
Class II · Moderate risk Terminated
Gaviscon Liquid Antacid Extra Strength
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Subpotent drug - Product did not contain drug.