Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITestosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIStanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIProgesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPrilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPhentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIOxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINaltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIMedroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILiothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILevothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILevofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILevocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILevetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IILeucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIKetoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIKetoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIKetamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIItraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIImiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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