FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated Feb 9, 2018

Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); 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 58597-8032-4 D-0529-2018

Class II · Moderate risk Terminated Feb 9, 2018

Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 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 58597-8546-4 D-0528-2018

Class II · Moderate risk Terminated Feb 9, 2018

Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); 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 58597-0079-4 D-0527-2018

Class II · Moderate risk Terminated Feb 9, 2018

Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 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 58597-0078-6 D-0526-2018

Class II · Moderate risk Terminated Feb 9, 2018

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 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 58597-0077-4 D-0525-2018

Class II · Moderate risk Terminated Feb 9, 2018

Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4)…

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 58597-8538-2 D-0524-2018

Class II · Moderate risk Terminated Feb 9, 2018

Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), 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 58597-8029-4 D-0523-2018

Class II · Moderate risk Terminated Feb 9, 2018

Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); 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 58597-8089-3 D-0522-2018

Class II · Moderate risk Terminated Feb 9, 2018

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650…

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 58597-8633-4 D-0521-2018

Class II · Moderate risk Terminated Feb 9, 2018

Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); 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 58597-8525-3 D-0520-2018

Class II · Moderate risk Terminated Feb 9, 2018

Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (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 58597-8088-2 D-0519-2018

Class II · Moderate risk Terminated Feb 9, 2018

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (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 58597-8471-1 D-0518-2018

Class II · Moderate risk Terminated Feb 9, 2018

Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g…

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 58597-8028-6 D-0517-2018

Class II · Moderate risk Terminated Feb 9, 2018

Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); 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 58597-8077-3 D-0516-2018

Class II · Moderate risk Terminated Feb 9, 2018

Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), 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 58597-8429-4 D-0515-2018

Class II · Moderate risk Terminated Feb 9, 2018

Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); 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 58597-0082-4 D-0514-2018

Class II · Moderate risk Terminated Feb 9, 2018

Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); 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 58597-8025-2 D-0513-2018

Class II · Moderate risk Terminated Feb 9, 2018

Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); 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 58597-0081-4 D-0512-2018

Class II · Moderate risk Terminated Feb 9, 2018

Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); 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 58597-8407-1 D-0511-2018

Class II · Moderate risk Terminated Feb 9, 2018

Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical…

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 58597-8055-8 D-0510-2018

Class II · Moderate risk Terminated Feb 9, 2018

Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650…

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 58597-8021-2 D-0509-2018

Class II · Moderate risk Terminated Feb 9, 2018

Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g…

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 58597-8359-6 D-0508-2018

Class II · Moderate risk Terminated Feb 9, 2018

Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); 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 58597-8019-4 D-0507-2018

Class II · Moderate risk Terminated Feb 9, 2018

Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); 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 58597-8020-6 D-0506-2018

Class II · Moderate risk Terminated Feb 9, 2018

Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), 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 58597-8638-1 D-0505-2018