Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2019

Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,788 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2019 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Timolol Maleate Sterile Opthalmic Solution

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.

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

Timolol Maleate USP

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.

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

Colostat

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

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

MYORISAN (isotretinoin capsules, USP)

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.

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

Clobetasol Propionate Foam

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

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

Clobetasol Propionate Foam

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

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

Yeast Arrest

cGMP violations

Terminated cGMP deviation Wisconsin Pharmacal Company, LLC NDC 68093-0730-1 D-0781-2020
Class I · High risk

Silver Bullet

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

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

fentaNYL 550 mcg/55 mL

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

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

fentaNYL 1500 mcg/30 mL

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

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

fentaNYL 2500 mcg/50 mL

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

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

fentaNYL 800 mcg/200 mL

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

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

fentaNYL 1000 mcg/20 mL

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

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

fentaNYL 200 mcg/100 mL

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

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

fentaNYL 400 mcg/200 mL

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

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

fentaNYL 400 mcg/200 mL

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

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

fentaNYL 200 mcg/100 mL

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

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

fentaNYL 250 mcg/5 mL

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

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1098-44 D-0560-2020

Recalls by year