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

9901–9925 of 17987

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-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-0513-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Nifedipine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2018·2018-02-28
FDA Recalls Testosterone Cypionate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Testosterone Cypionate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0528-2018·2018-02-28
FDA Recalls Testosterone USP Micronized for Prescription Compounding
American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
Product
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
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-0481-2018·2018-02-28
Cyclobenzaprine HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), 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-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-0504-2018·2018-02-28
Levofloxacin Hemihydrate Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.
Product
Levofloxacin 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0529-2018·2018-02-28
FDA Recalls Tramadol HCl for Prescription Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Tramadol HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), 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
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-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-0520-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.
Product
Stanozolol 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0532-2018·2018-02-28
FDA Recalls Vancomycin HCl Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Vancomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2018·2018-02-28
Pentoxifylline USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Pentoxifylline 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0522-2018·2018-02-28
Sumatriptan USP for Prescription Compounding Recalled Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Sumatriptan USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.
Product
Sumatriptan 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2018·2018-02-28
FDA Recalls Hydroxyprogesterone Caproate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Hydroxyprogesterone Caproate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0531-2018·2018-02-28
Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls
American Pharmaceutical Ingredients is recalling Ursodiol USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
Product
Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), 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-0474-2018·2018-02-28
Amitriptyline HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data supporting the assigned expiration dates.
Product
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide
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-0514-2018·2018-02-28
Oxandrolone USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.
Product
Oxandrolone 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
Category
Drug
Distribution
Distributed nationwide

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9901–9925 of 17987