US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

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

Estradiol Hemihydrate 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 58597-8001-3 D-0489-2018
Class II · Moderate risk Terminated

Estradiol 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 58597-8047-1 D-0488-2018
Class II · Moderate risk Terminated

Duloxetine 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 58597-8632-6 D-0487-2018
Class II · Moderate risk Terminated

Doxycycline Hyclate 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 58597-8082-4 D-0486-2018
Class II · Moderate risk Terminated

Diphenhydramine HCl USP f

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 58597-8081-4 D-0485-2018
Class II · Moderate risk Terminated

Diclofenac 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 58597-8012-4 D-0484-2018
Class II · Moderate risk Terminated

Desoximetasone 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 58597-8634-2 D-0483-2018
Class II · Moderate risk Terminated

Cyclosporine 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 58597-8210-2 D-0482-2018
Class II · Moderate risk Terminated

Cyclobenzaprine 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 58597-8011-4 D-0481-2018
Class II · Moderate risk Terminated

Clonidine 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 58597-8010-2 D-0480-2018
Class II · Moderate risk Terminated

Clindamycin Phosphate 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 58597-8198-3 D-0479-2018
Class II · Moderate risk Terminated

Celecoxib 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 58597-8635-4 D-0478-2018
Class II · Moderate risk Terminated

Calcipotriene BP

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 58597-8630-1 D-0477-2018
Class II · Moderate risk Terminated

Baclofen 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 58597-8004-4 D-0476-2018
Class II · Moderate risk Terminated

Anastrozole 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 58597-8080-1 D-0475-2018
Class II · Moderate risk Terminated

Amitriptyline 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 58597-8003-4 D-0474-2018