US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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

Timolol Maleate Sterile Opthalmic Solution

Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Rising Pharmaceuticals, Inc. NDC 64980-513-05 D-1368-2020
Class III · Low risk Terminated

Timolol Maleate USP

Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Rising Pharmaceuticals, Inc. NDC 64980-514-05 D-1367-2020
Class III · Low risk Terminated

Colostat

Reason Labeling mix-up - Indications on product label are incorrect.

Grato Holdings, Inc. NDC 44911-0411-1 D-1049-2020
Class II · Moderate risk Terminated

Myorisan

Reason Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.

Akorn, Inc. NDC 61748-302-13 D-0647-2020
Class III · Low risk Terminated

Clobetasol Propionate Foam

Reason Defective delivery system; product is not foaming or is coming out as liquid.

Glenmark Pharmaceuticals Inc., USA NDC 68462-625-27 D-0619-2020
Class III · Low risk Terminated

Clobetasol Propionate Foam

Reason Defective delivery system; product is not foaming or is coming out as liquid.

Glenmark Pharmaceuticals Inc., USA NDC 68462-608-27 D-0618-2020
Class II · Moderate risk Terminated

Yeast Arrest

Reason cGMP violations

Wisconsin Pharmacal Company, LLC NDC 68093-0730-1 D-0781-2020
Class II · Moderate risk Terminated

AVKARE Ranitidine Tablets

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc. NDC 42291-725-25 D-0525-2020
Class II · Moderate risk Terminated

AVKARE Ranitidine Tablets

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc. NDC 42291-724-10 D-0524-2020
Class II · Moderate risk Terminated

Ranitidine Oral Solution

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

Precision Dose Inc. D-1004-2020
Class I · High risk Terminated

Silver Bullet

Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

Natures Rx D-0633-2020
Class II · Moderate risk Terminated

fentaNYL 550 mcg/55 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1274-50 D-0572-2020
Class II · Moderate risk Terminated

fentaNYL 1000 mcg/100 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1250-75 D-0571-2020
Class II · Moderate risk Terminated

fentaNYL 1500 mcg/30 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1180-79 D-0570-2020
Class II · Moderate risk Terminated

fentaNYL 2500 mcg/50 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1436-76 D-0569-2020
Class II · Moderate risk Terminated

fentaNYL 800 mcg/200 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1436-76 D-0568-2020
Class II · Moderate risk Terminated

fentaNYL 1250 mcg/250 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1444-05 D-0567-2020
Class II · Moderate risk Terminated

fentaNYL 1000 mcg/20 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1415-47 D-0566-2020
Class II · Moderate risk Terminated

fentaNYL 200 mcg/100 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1103-36 D-0565-2020
Class II · Moderate risk Terminated

fentaNYL 400 mcg/200 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1441-76 D-0564-2020
Class II · Moderate risk Terminated

fentaNYL 2000 mcg/100 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1094-36 D-0563-2020
Class II · Moderate risk Terminated

fentaNYL 400 mcg/200 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1207-37 D-0562-2020
Class II · Moderate risk Terminated

fentaNYL 200 mcg/100 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1108-36 D-0561-2020
Class II · Moderate risk Terminated

fentaNYL 250 mcg/5 mL

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1098-44 D-0560-2020