US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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

H-E-B - Athlete's Foot Cream Clotrimazole Cream USP

Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Taro Pharmaceuticals U.S.A., Inc. NDC 37808-305-01 D-0152-2021
Class II · Moderate risk Terminated

Equate Athlete's Foot

Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Taro Pharmaceuticals U.S.A., Inc. NDC 49035-812-01 D-0151-2021
Class II · Moderate risk Terminated

CVS Health Athlete's Foot Cream

Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Taro Pharmaceuticals U.S.A., Inc. NDC 59779-305-03 D-0150-2021
Class I · High risk Terminated

Regenecare Ha

Reason Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

MPM Medical LLC NDC 66977-107-03 D-0118-2021
Class II · Moderate risk Terminated

Aripiprazole Tablets

Reason FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets

Golden State Medical Supply Inc. NDC 60429-449-30 D-0112-2021
Class III · Low risk Terminated

DOXOrubicin Hydrochloride Injection

Reason Cross Contamination with Other Products: trace amounts of octreotide found during testing

Fresenius Kabi USA, LLC D-0105-2021
Class III · Low risk Terminated

Levocetirizine Dihydrochloride Tablets

Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

InvaTech Pharma Solutions, LLC NDC 10135-0639-30 D-0115-2021
Class II · Moderate risk Terminated

Aripiprazole Tablets

Reason Failed Dissolution Specifications: Out of specification for dissolution.

Apotex Corp. NDC 60505-2675-8 D-0106-2021
Class III · Low risk Terminated

Testosterone Gel 1%

Reason Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

Teva Pharmaceuticals USA NDC 0591-3216-17 D-0100-2021
Class II · Moderate risk Terminated

Levetiracetam Tablets

Reason Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.

Eywa Pharma INC NDC 71930-063-52 D-0109-2021
Class II · Moderate risk Terminated

clomiPRAMINE Hydrochloride Capsules USP

Reason Failed Tablet/Capsule Specification

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-711-30 D-0104-2021
Class III · Low risk Terminated

Triamcinolone Acetonide Lotion USP

Reason Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

Teligent Pharma, Inc. NDC 52565-010-59 D-0110-2021
Class II · Moderate risk Terminated

Sodium Chloride Injection

Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.

Hikma Pharmaceuticals USA Inc. NDC 0641-0497-17 D-0101-2021
Class II · Moderate risk Terminated

Metformin HCl Extended Release Tablets USP 500 mg

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Preferred Pharmaceuticals, Inc. D-0077-2021
Class I · High risk Terminated

Chlorhexidine Gluconate Oral Rinse USP

Reason Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Lohxa LLC NDC 70166-027-15 D-0111-2021
Class II · Moderate risk Terminated

Mesalamine Delayed-Release Tablets

Reason Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Teva Pharmaceuticals USA NDC 0591-2245-22 D-0069-2021
Class II · Moderate risk Terminated

Hydrocodone Bitartrate and Acetaminophen Tablets

Reason Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.

Ascent Pharmaceuticals, Inc. NDC 31722-943-01 D-0097-2021
Class III · Low risk Terminated

Felodipine Extended Release Tablets

Reason Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

Heritage Pharmaceuticals Inc NDC 23155-050-01 D-0108-2021