Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9801–9825 of 17785

ModerateFDA (Drugs)·D-0496-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
Product
Imiquimod 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0525-2018·2018-02-28
FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
Product
Testosterone (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,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0492-2018·2018-02-28
Fluconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.
Product
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0479-2018·2018-02-28
FDA Recalls Clindamycin Phosphate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2018·2018-02-28
Lidocaine HCl USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Lidocaine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2018·2018-02-28
Lincomycin HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lincomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Lincomycin 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0485-2018·2018-02-28
FDA Recalls Diphenhydramine HCl Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned expiration date.
Product
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2018·2018-02-28
Flurbiprofen USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2018·2018-02-28
Prilocaine HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Prilocaine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0512-2018·2018-02-28
Nandrolone Decanoate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Nandrolone 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.
Product
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0539-2018·2018-02-28
Fluticasone Propionate USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Fluticasone propionate USP for prescription compounding due to a lack of stability data and controls to support expiration dates.
Product
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2018·2018-02-28
FDA Recalls Itraconazole USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Itraconazole USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Itraconazole 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 483
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0536-2018·2018-02-28
Biotin USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.
Product
Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2018·2018-02-28
Ketoconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Ketoconazole USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
Product
Ketoconazole 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0518-2018·2018-02-28
Progesterone USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Progesterone USP for prescription compounding due to CGMP deviations involving missing stability data and controls.
Product
Progesterone 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0490-2018·2018-02-28
FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support expiration dates.
Product
Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0476-2018·2018-02-28
Baclofen USP Micronized Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Baclofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0534-2018·2018-02-28
Verapamil HCl USP Recalled for Missing Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Verapamil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
Product
Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0505-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.
Product
Levothyroxine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0477-2018·2018-02-28
FDA Recalls Calcipotriene BP Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Calcipotriene BP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2018·2018-02-28
FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Testosterone Enanthate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0516-2018·2018-02-28
Phentolamine Mesylate Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate USP for prescription compounding due to missing stability data supporting expiration dates.
Product
Phentolamine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2018·2018-02-28
Levocetirizine Dihydrochloride Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Levocetirizine Dihydrochloride for prescription compounding due to a lack of stability data supporting the expiration date.
Product
Levocetirizine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0475-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Anastrozole USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Anastrozole USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.
Product
Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide

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9801–9825 of 17785