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

Amitiza

Reason Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.

Mallinckrodt Pharmaceuticals NDC 64764-080-60 D-1294-2019
Class I · High risk Terminated

Promacta

Reason Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

Novartis Pharmaceuticals Corp. NDC 0078-0972-61 D-1309-2019
Class III · Low risk Terminated

QUIK-CARE Aerosol Foam Hand Sanitizer

Reason Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

Ecolab Inc NDC 47593-490-82 D-1393-2019
Class II · Moderate risk Terminated

Anastrozole Tablets

Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.

American Health Packaging NDC 68001-155-04 D-1467-2019
Class II · Moderate risk Terminated

Anastrozole Tablets

Reason GMP Deviations: Potential cross contamination due to cleaning procedure failure.

American Health Packaging NDC 60687-112-21 D-1394-2019
Class II · Moderate risk Terminated

MethylPREDNISolone Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-917-11 D-1453-2019
Class II · Moderate risk Terminated

MethylPREDNISolone Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-919-11 D-1451-2019
Class II · Moderate risk Terminated

MethylPREDNISolone Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-918-18 D-1450-2019
Class II · Moderate risk Terminated

MethylPREDNISolone Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-916-34 D-1449-2019
Class II · Moderate risk Terminated

MethylPREDNISolone Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-916-01 D-1448-2019
Class II · Moderate risk Terminated

Pramipexole Dihydrochloride Tablets 1 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-199-16 D-1447-2019
Class II · Moderate risk Terminated

Pramipexole Dihydrochloride Tablets 0.5 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-198-16 D-1446-2019
Class II · Moderate risk Terminated

Pramipexole Dihydrochloride Tablets 0.25 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-197-10 D-1445-2019
Class II · Moderate risk Terminated

Pramipexole Dihydrochoride Tablets 0.25 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-197-16 D-1444-2019
Class II · Moderate risk Terminated

Pramipexole DihydrochlorideTablets 0.125 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-196-16 D-1443-2019
Class II · Moderate risk Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-196-10 D-1442-2019
Class II · Moderate risk Terminated

Anastrozole Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-209-10 D-1441-2019
Class II · Moderate risk Terminated

ANASTROZOLE Tablets

Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Zydus Pharmaceuticals USA Inc NDC 68382-209-06 D-1440-2019
Class II · Moderate risk Terminated

Senna

Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Geritrex, LLC NDC 54162-007-08 D-1437-2019
Class II · Moderate risk Terminated

Senna

Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Geritrex, LLC NDC 53807-556-08 D-1436-2019
Class I · High risk Terminated

The Beast

Reason Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.

Stiff Boy LLC D-1321-2019
Class II · Moderate risk Terminated

Bevacizumab 2.5 mg/0.1 mL

Reason Lack of assurance of sterility

Avella of Deer Valley, Inc. Store 38 NDC 42852-001-27 D-1308-2019
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx…

Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Heritage Pharmaceuticals, Inc. NDC 23155-644-09 D-1291-2019
Class II · Moderate risk Terminated

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx…

Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Heritage Pharmaceuticals, Inc. NDC 23155-646-10 D-1290-2019