FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated Feb 9, 2018

Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8085-6 D-0504-2018

Class II · Moderate risk Terminated Feb 9, 2018

Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8355-6 D-0503-2018

Class II · Moderate risk Terminated Feb 9, 2018

Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only…

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

American Pharmaceutical Ingredients LLC NDC 58597-8353-7 D-0502-2018

Class II · Moderate risk Terminated Feb 9, 2018

Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8084-1 D-0501-2018

Class II · Moderate risk Terminated Feb 9, 2018

Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8336-4 D-0500-2018

Class II · Moderate risk Terminated Feb 9, 2018

Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8053-4 D-0499-2018

Class II · Moderate risk Terminated Feb 9, 2018

Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8333-4 D-0498-2018

Class II · Moderate risk Terminated Feb 9, 2018

Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8133-3 D-0497-2018

Class II · Moderate risk Terminated Feb 9, 2018

Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8317-1 D-0496-2018

Class II · Moderate risk Terminated Feb 9, 2018

Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8051-4 D-0495-2018

Class II · Moderate risk Terminated Feb 9, 2018

Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8014-4 D-0494-2018

Class II · Moderate risk Terminated Feb 9, 2018

Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8075-4 D-0493-2018

Class II · Moderate risk Terminated Feb 9, 2018

Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8268-4 D-0492-2018

Class II · Moderate risk Terminated Feb 9, 2018

Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8049-3 D-0491-2018

Class II · Moderate risk Terminated Feb 9, 2018

Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c)…

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

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

Class II · Moderate risk Terminated Feb 9, 2018

Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8001-3 D-0489-2018

Class II · Moderate risk Terminated Feb 9, 2018

Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c)…

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

American Pharmaceutical Ingredients LLC NDC 58597-8047-1 D-0488-2018

Class II · Moderate risk Terminated Feb 9, 2018

Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only…

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

American Pharmaceutical Ingredients LLC NDC 58597-8632-6 D-0487-2018

Class II · Moderate risk Terminated Feb 9, 2018

Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g…

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

American Pharmaceutical Ingredients LLC NDC 58597-8082-4 D-0486-2018

Class II · Moderate risk Terminated Feb 9, 2018

Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX…

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

American Pharmaceutical Ingredients LLC NDC 58597-8081-4 D-0485-2018

Class II · Moderate risk Terminated Feb 9, 2018

Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g…

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

American Pharmaceutical Ingredients LLC NDC 58597-8012-4 D-0484-2018

Class II · Moderate risk Terminated Feb 9, 2018

Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8634-2 D-0483-2018

Class II · Moderate risk Terminated Feb 9, 2018

Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8210-2 D-0482-2018

Class II · Moderate risk Terminated Feb 9, 2018

Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g…

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

American Pharmaceutical Ingredients LLC NDC 58597-8011-4 D-0481-2018

Class II · Moderate risk Terminated Feb 9, 2018

Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC…

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

American Pharmaceutical Ingredients LLC NDC 58597-8010-2 D-0480-2018