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Teva Pharmaceuticals USA

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
201812
20196
202022
202153
20227
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FDA 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.
Published
August 1, 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 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.
Published
August 1, 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 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.
Published
August 1, 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 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA 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.
Published
August 1, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.

by Teva Pharmaceuticals USA

Reason
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Published
July 18, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications
Published
May 30, 2018
Distribution
United States

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FDA Recall Terminated Historical recordClass II

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Published
March 28, 2018
Distribution
Distributed within the United States and…

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This page lists recalls that name Teva Pharmaceuticals USA as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.