US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Tacrolimus 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 58597-8029-4 D-0523-2018
Class II · Moderate risk Terminated

Sumatriptan 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 58597-8089-3 D-0522-2018
Class II · Moderate risk Terminated

Sumatriptan Succinate 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 58597-8633-4 D-0521-2018
Class II · Moderate risk Terminated

Stanozolol 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 58597-8525-3 D-0520-2018
Class II · Moderate risk Terminated

Sildenafil Citrate 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 58597-8088-2 D-0519-2018
Class II · Moderate risk Terminated

Progesterone 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 58597-8471-1 D-0518-2018
Class II · Moderate risk Terminated

Prilocaine 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 58597-8028-6 D-0517-2018
Class II · Moderate risk Terminated

Phentolamine Mesylate 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 58597-8077-3 D-0516-2018
Class II · Moderate risk Terminated

Pentoxifylline 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 58597-8429-4 D-0515-2018
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