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Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.

37,118

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls

Most common hazardLack of Assurance of Sterility 2,072 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gf-blends-recalls-truly-aip-all-purpose-flour-and-bread-mix-and-eat-gangster-flat-bread-pizza-mixPublished September 18, 2026

Most affected stateHawaii 200 recalls mention this state

State: PR ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 20, 2026 ET

Summary (Year to date)

1,527 recalls have been announced year to date.
Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
The highest complete period was Jun 2026 (297).
Sep 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

View recall →

FDA 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.
Published: December 19, 2018
Distribution: Product was distributed throughout the U…

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FDA 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.
Published: December 19, 2018
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), 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.
Published: December 19, 2018
Distribution: Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03

by Westminster Pharmaceuticals LLC

Reason: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Published: December 19, 2018
Distribution: Nationwide

View recall →

Data last updated: September 20, 2026 ET

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.