US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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

Oxandrolone USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-0082-4 D-0514-2018
Class II · Moderate risk Terminated

Nifedipine USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8025-2 D-0513-2018
Class II · Moderate risk Terminated

Nandrolone Decanoate USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-0081-4 D-0512-2018
Class II · Moderate risk Terminated

Naltrexone HCl USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8407-1 D-0511-2018
Class II · Moderate risk Terminated

Medroxyprogesterone Acetate USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8055-8 D-0510-2018
Class II · Moderate risk Terminated

Liothyronine Sodium USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8021-2 D-0509-2018
Class II · Moderate risk Terminated

Lincomycin HCl USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8359-6 D-0508-2018
Class II · Moderate risk Terminated

Lidocaine USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8019-4 D-0507-2018
Class II · Moderate risk Terminated

Lidocaine HCl USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8020-6 D-0506-2018
Class II · Moderate risk Terminated

Levothyroxine Sodium USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8638-1 D-0505-2018
Class II · Moderate risk Terminated

Levofloxacin Hemihydrate USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8085-6 D-0504-2018
Class II · Moderate risk Terminated

Levocetirizine Dihydrochloride for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8355-6 D-0503-2018
Class II · Moderate risk Terminated

Levetiracetam USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8353-7 D-0502-2018
Class II · Moderate risk Terminated

Leucovorin Calcium USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8084-1 D-0501-2018
Class II · Moderate risk Terminated

Ketoprofen USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8336-4 D-0500-2018
Class II · Moderate risk Terminated

Ketoconazole USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8053-4 D-0499-2018
Class II · Moderate risk Terminated

Ketamine HCl USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8333-4 D-0498-2018
Class II · Moderate risk Terminated

Itraconazole USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8133-3 D-0497-2018
Class II · Moderate risk Terminated

Imiquimod USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8317-1 D-0496-2018
Class II · Moderate risk Terminated

Hydroxyprogesterone Caproate USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8051-4 D-0495-2018
Class II · Moderate risk Terminated

Gabapentin USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8014-4 D-0494-2018
Class II · Moderate risk Terminated

Flurbiprofen USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8075-4 D-0493-2018
Class II · Moderate risk Terminated

Fluconazole USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8268-4 D-0492-2018
Class II · Moderate risk Terminated

Estrone USP for prescription compounding

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8049-3 D-0491-2018
Class II · Moderate risk Terminated

Estriol USP

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

American Pharmaceutical Ingredients LLC NDC 58597-8048-2 D-0490-2018