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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 9,261–9,280 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.

by PD-Rx Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Recall initiated
August 7, 2018
Reported by FDA
September 5, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA

by Living Well Remedies, LLC

Reason
Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Recall initiated
August 13, 2018
Reported by FDA
September 5, 2018
Distribution
United States

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Drug Recall Terminated Historical recordClass I

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.

by Westminster Pharmaceuticals LLC

Reason
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Recall initiated
August 3, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.

by Westminster Pharmaceuticals LLC

Reason
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Recall initiated
August 3, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04.

by Westminster Pharmaceuticals LLC

Reason
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Recall initiated
August 3, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04.

by Westminster Pharmaceuticals LLC

Reason
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Recall initiated
August 3, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.

by Westminster Pharmaceuticals LLC

Reason
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Recall initiated
August 3, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass II

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902

by Hetero Labs Limited Unit V

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
August 8, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905

by Hetero Labs Limited Unit V

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
August 8, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908

by Hetero Labs Limited Unit V

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
August 8, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307

by Hetero Labs Limited Unit V

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
August 8, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Recall initiated
August 14, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

by A-S Medication Solutions LLC.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0

by A-S Medication Solutions LLC.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

by A-S Medication Solutions LLC.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

by A-S Medication Solutions LLC.

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 17, 2018
Reported by FDA
August 29, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

by Preferred Pharmaceuticals, Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
August 15, 2018
Reported by FDA
August 29, 2018
Distribution
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.

View recall →

Drug Recall Terminated Historical recordClass III

Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recall initiated
August 14, 2018
Reported by FDA
August 29, 2018
Distribution
Product was distributed throughout the United States to wholesalers and retailers.

View recall →

Drug Recall Terminated Historical recordClass III

Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recall initiated
August 14, 2018
Reported by FDA
August 29, 2018
Distribution
Product was distributed throughout the United States to wholesalers and retailers.

View recall →

Drug Recall Terminated Historical recordClass III

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recall initiated
August 14, 2018
Reported by FDA
August 29, 2018
Distribution
Product was distributed throughout the United States to wholesalers and retailers.

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.