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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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Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.

by Mylan Laboratories Limited, (Nashik FDF)

Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall initiated: December 4, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

by Mylan Pharmaceuticals Inc.

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recall initiated: November 20, 2018
Reported by FDA: December 19, 2018
Distribution: Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Recall initiated: November 27, 2018
Reported by FDA: December 19, 2018
Distribution: USA Nationwide including Puerto Rico.

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Data last updated: September 22, 2026 ET

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.