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

FDA Drug Recalls

316 recalls, newest first

Apr 19, 2023 Class II · Moderate risk

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Ongoing Impurity / degradation Seatex LLC D-0562-2023

Apr 13, 2023 Class II · Moderate risk

C-Semaglutide 5mg/mL injection

Lack of assurance of sterility.

Ongoing Sterility / contamination Pharmacy Plus, Inc. dba Vital Care Compounder D-0538-2023

Apr 11, 2023 Class II · Moderate risk

Admelog

Lack of Assurance of Sterility: Malformed crimped collar seal

Ongoing Sterility / contamination Sanofi-Aventis U.S. LLC NDC 0024-5926-05 D-0575-2023

Apr 6, 2023 Class II · Moderate risk

Fast Acting Earwax Removal System

CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Ongoing Wrong potency / content Pharma Nobis LLC D-0537-2023

Mar 31, 2023 Class II · Moderate risk

Advil Liqui-Gels Solubilized Ibuprofen Capsules

CGMP deviation: product outside labeled storage temperature requirements.

Ongoing Temperature excursion Family Dollar Stores, Llc. D-0566-2023

Mar 31, 2023 Class II · Moderate risk

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen

CGMP deviation: product outside labeled storage temperature requirements.

Ongoing Temperature excursion Family Dollar Stores, Llc. D-0565-2023

Mar 31, 2023 Class II · Moderate risk

Advil Ibuprofen Tablets

CGMP deviation: product outside labeled storage temperature requirements.

Ongoing Temperature excursion Family Dollar Stores, Llc. D-0564-2023

Mar 31, 2023 Class II · Moderate risk

Advil Ibuprofen Tablets

CGMP deviation: product outside labeled storage temperature requirements.

Ongoing Temperature excursion Family Dollar Stores, Llc. D-0563-2023

Mar 23, 2023 Class II · Moderate risk

Glimepiride Tablets USP

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8066-9 D-0527-2023

Mar 23, 2023 Class II · Moderate risk

Tadalafil Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8153-7 D-0526-2023

Mar 23, 2023 Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023

Mar 23, 2023 Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9869-9 D-0524-2023

Mar 23, 2023 Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9429-9 D-0523-2023

Mar 23, 2023 Class II · Moderate risk

Simvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9747-9 D-0522-2023

Mar 23, 2023 Class II · Moderate risk

Pravastatin Sodium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023

Mar 23, 2023 Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023

Mar 23, 2023 Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023

Mar 23, 2023 Class II · Moderate risk

Montelukast Sodium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-9438-3 D-0518-2023

Mar 23, 2023 Class II · Moderate risk

Glimepiride Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8095-9 D-0517-2023

Mar 23, 2023 Class II · Moderate risk

Finasteride Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-6976-3 D-0516-2023

Mar 23, 2023 Class II · Moderate risk

Doxazosin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7149-1 D-0515-2023

Mar 23, 2023 Class II · Moderate risk

Doxazosin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7328-1 D-0514-2023

Mar 23, 2023 Class II · Moderate risk

Clopidogrel Tablets USP

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8190-9 D-0513-2023

Mar 23, 2023 Class II · Moderate risk

Atorvastatin Calcium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7631-9 D-0512-2023

Mar 23, 2023 Class II · Moderate risk

Atorvastatin Calcium Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7630-9 D-0511-2023

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061