US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Esomeprazole Magnesium Delayed-Release Capsules

Reason Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 42292-009-16 D-0860-2022
Class II · Moderate risk Terminated

Travoprost Ophthalmic Solution

Reason Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.

Mylan Pharmaceuticals Inc NDC 0378-9651-32 D-0748-2022
Class II · Moderate risk Ongoing

CBD Metered Dose Inhaler

Reason Marketed Without an Approved NDA/ANDA

Wellness BioSciences D-0541-2023
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-378-03 D-0840-2022
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-377-03 D-0839-2022
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-376-03 D-0838-2022
Class II · Moderate risk Terminated

Janumet

Reason Presence of foreign substance: Presence of stainless steel particulates in tablets.

Merck Sharp & Dohme CORP NDC 0006-0575-02 D-0746-2022
Class II · Moderate risk Terminated

Preferred Pharmaceuticals

Reason Out of specification results observed in dissolution during long term stability testing.

Preferred Pharmaceuticals, Inc. NDC 68788-6390-09 D-0769-2022
Class II · Moderate risk Completed

Magnesium Hydroxide 1200mg

Reason CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC D-0871-2022
Class II · Moderate risk Completed

Milk of Magnesia USP

Reason CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC NDC 0904-6846-73 D-0870-2022
Class II · Moderate risk Completed

Acetaminophen Oral Solution

Reason CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC D-0869-2022
Class II · Moderate risk Terminated

Diclofenac Sodium Topical Solution 1.5% w/w

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Preferred Pharmaceuticals, Inc. NDC 68788-7918-01 D-0773-2022
Class II · Moderate risk Terminated

Econazole Nitrate Cream

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Preferred Pharmaceuticals, Inc. NDC 68788-7406-03 D-0771-2022
Class II · Moderate risk Terminated

Clobetasol Propionate Lotion 0.05%

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Preferred Pharmaceuticals, Inc. NDC 68788-7768-01 D-0768-2022
Class II · Moderate risk Terminated

Lansoprazole Delayed-Release Capsules

Reason Failed Dissolution Specifications; during long term stability testing.

Dr. Reddy's Laboratories, Inc. NDC 55111-399-90 D-0738-2022
Class II · Moderate risk Terminated

Lansoprazole Delayed-Release Capsules

Reason Failed Dissolution Specifications; during long term stability testing.

Dr. Reddy's Laboratories, Inc. NDC 55111-398-30 D-0737-2022
Class II · Moderate risk Terminated

Testosterone Cypionate *gs*

Reason Lack of sterility assurance.

Drug Depot, Inc., dba APS Pharmacy D-0735-2022