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

9976–10000 of 18028

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-0509-2018·2018-02-28
Liothyronine Sodium USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Liothyronine Sodium USP for prescription compounding due to a lack of stability data supporting the expiration date.
Product
Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0523-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Tacrolimus USP Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling specific lots of Tacrolimus USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Tacrolimus 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
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-0486-2018·2018-02-28
FDA Recalls Doxycycline Hyclate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), 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-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-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-0521-2018·2018-02-28
Sumatriptan Succinate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Sumatriptan Succinate USP for prescription compounding due to a lack of stability data supporting the expiration date.
Product
Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0501-2018·2018-02-28
FDA Recalls Leucovorin Calcium Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Leucovorin Calcium USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Leucovorin 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0494-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding
American Pharmaceutical Ingredients LLC is recalling Gabapentin USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.
Product
Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0507-2018·2018-02-28
Lidocaine USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Lidocaine 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2018·2018-02-28
Ketoprofen USP Micronized Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Ketoprofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Ketoprofen 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 4832
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-0511-2018·2018-02-28
Naltrexone HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Naltrexone HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Naltrexone 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0538-2018·2018-02-28
FDA Recalls Vitamin B12 Compounding Ingredient Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Cyanocobalamin USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
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-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-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-0510-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.
Product
Medroxyprogesterone 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
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-0489-2018·2018-02-28
FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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-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-0484-2018·2018-02-28
FDA Recalls Diclofenac Sodium USP Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diclofenac Sodium USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide

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9976–10000 of 18028