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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.

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Showing 9,361–9,380 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

by Bryant Ranch Prepack Inc.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 27, 2018
Reported by FDA
August 8, 2018
Distribution
Product was distributed in HI, IN, and FL.

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04

by MAJOR PHARMACEUTICALS

Reason
Failed Dissolution Specifications
Recall initiated
July 30, 2018
Reported by FDA
August 8, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.

by West-Ward Columbus Inc

Reason
Failed Dissolution Specifications:
Recall initiated
July 24, 2018
Reported by FDA
August 8, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.

by West-Ward Columbus Inc

Reason
Failed Dissolution Specifications:
Recall initiated
July 24, 2018
Reported by FDA
August 8, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

by Pfizer

Reason
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Recall initiated
June 28, 2018
Reported by FDA
August 8, 2018
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.

by H J Harkins Company Inc dba Pharma Pac

Reason
Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 26, 2018
Reported by FDA
August 8, 2018
Distribution
Product was distributed to a physician's office.

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Drug Recall Terminated Historical recordClass II

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

by RemedyRePack Inc.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 8, 2018
Distribution
Product was distributed to 3 medical facilities in Florida.

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Drug Recall Terminated Historical recordClass II

Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

by RemedyRePack Inc.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 8, 2018
Distribution
Product was distributed to 3 medical facilities in Florida.

View recall →

Drug Recall Terminated Historical recordClass II

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

by Hetero Labs, Ltd. - Unit III

Reason
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Recall initiated
July 18, 2018
Reported by FDA
August 8, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.

by VENSUN PHARMACEUTICALS INC

Reason
Failed Tablet/Capsule Specifications: Tablet breakage
Recall initiated
July 18, 2018
Reported by FDA
August 8, 2018
Distribution
Within the United States and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

by VENSUN PHARMACEUTICALS INC

Reason
Failed Tablet/Capsule Specifications: Tablet breakage
Recall initiated
July 18, 2018
Reported by FDA
August 8, 2018
Distribution
Within the United States and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Recall initiated
June 27, 2018
Reported by FDA
August 1, 2018
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Recall initiated
June 27, 2018
Reported by FDA
August 1, 2018
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

by Aidarex Pharmaceuticals LLC

Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Recall initiated
June 27, 2018
Reported by FDA
August 1, 2018
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

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.

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 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

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 Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

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 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

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 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.

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 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

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 →

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.