Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,711 recalls, newest first

Class III · Low risk

Donnatal

Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

Terminated Labeling / mix-up Rx PAK NDC 59212-425-10 D-0053-2016
Class II · Moderate risk

Testosterone USP 99.5%

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination Qualgen NDC 69761-125-01 D-0387-2016
Class II · Moderate risk

Estradiol USP 99.5%

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination Qualgen NDC 69761-006-01 D-0386-2016
Class II · Moderate risk

PGE 25mcg/ml

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0180-2016
Class II · Moderate risk

Papa/Pge1/Phento

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0179-2016
Class II · Moderate risk

Papa/Phento

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0178-2016
Class II · Moderate risk

PGE 30mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0177-2016

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