Class III · Low risk
Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
FDA Drug Recalls
832 recalls, newest first
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class I · High risk
Saniderm ADVANCED HAND SANITIZER
Chemical Contamination: Product contains undeclared methanol.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class II · Moderate risk
Metformin HCl Extended Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Childrens Dimetapp Cold & Cough
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk
Childrens Robitussin Honey Cough and Chest Congestion DM
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
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 III · Low risk
Nabumetone Tablets
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
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 I · High risk
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk
Prednisolone Sodium Phosphate Oral Solution
Discoloration: Out of Specification (OOS) result for APHA Color Test.