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

9326–9350 of 17785

SevereFDA (Drugs)·D-0983-2018·2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0971-2018·2018-08-01
Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc. is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0985-2018·2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0989-2018·2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0974-2018·2018-08-01
Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0967-2018·2018-08-01
Major Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Major Pharmaceuticals is recalling specific lots of 160 mg Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0988-2018·2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0986-2018·2018-08-01
Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API
Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0981-2018·2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0968-2018·2018-08-01
Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc. is recalling Valsartan 40 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0984-2018·2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0969-2018·2018-08-01
Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0982-2018·2018-08-01
Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0976-2018·2018-08-01
Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0966-2018·2018-08-01
Major Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Major Pharmaceuticals is recalling specific lots of 80 mg Valsartan tablets because a carcinogen impurity was detected in the active ingredient.
Product
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0970-2018·2018-08-01
Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0972-2018·2018-08-01
Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0973-2018·2018-08-01
Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0975-2018·2018-08-01
Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0977-2018·2018-08-01
Sun Pharmaceutical Recalls Testosterone Cypionate Injection Due to Particulate Matter
Sun Pharmaceutical Industries is recalling Testosterone Cypionate Injection vials because organic and inorganic particulate matter was detected in the product.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0979-2018·2018-08-01
Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities
Major Pharmaceuticals is recalling specific lots of Enalapril Maleate Tablets, 2.5 mg, because the product failed impurity specifications for a degradation product.
Product
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distribute
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0991-2018·2018-08-01
Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.
Product
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0990-2018·2018-08-01
Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.
Product
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0992-2018·2018-08-01
Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
Aidarex Pharmaceuticals is recalling 25 bottles of Enalapril Maleate 5mg due to out-of-specification degradation results during stability testing.
Product
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0980-2018·2018-08-01
Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities
Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.
Product
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed
Category
Drug
Distribution
Distributed nationwide

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9326–9350 of 17785