Skip to main content
Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters
Recall details
Location
Date range
Clear filters

Showing 9,381–9,400 of 17,974 drug recalls

Drug Recall Ongoing Historical recordClass II

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.

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 16, 2018
Reported by FDA
August 1, 2018
Distribution
Product was distributed throughout the United States, including Hawaii and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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.

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 16, 2018
Reported by FDA
August 1, 2018
Distribution
Product was distributed throughout the United States, including Hawaii and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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.

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 16, 2018
Reported by FDA
August 1, 2018
Distribution
Product was distributed throughout the United States, including Hawaii and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

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 by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.

by MAJOR PHARMACEUTICALS

Reason
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Recall initiated
June 26, 2018
Reported by FDA
August 1, 2018
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

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; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.

by MAJOR PHARMACEUTICALS

Reason
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Recall initiated
June 26, 2018
Reported by FDA
August 1, 2018
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Recall initiated
July 12, 2018
Reported by FDA
August 1, 2018
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Ongoing Historical recordClass II

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03

by Prinston Pharmaceutical Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 13, 2018
Reported by FDA
August 1, 2018
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass II

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

by MAJOR PHARMACEUTICALS

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
August 1, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

by MAJOR PHARMACEUTICALS

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
August 1, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated
June 12, 2018
Reported by FDA
July 25, 2018
Distribution
Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.