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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 Terminated Historical recordClass III

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.

by Teva Pharmaceuticals USA

Reason
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Published
November 25, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Published
November 18, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Published
October 7, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.

by Teva Pharmaceuticals USA

Reason
Sub-Potent Drug: Out of specification test results for potency (below specification).
Published
September 16, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Published
September 16, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Published
September 16, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Published
August 19, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published
July 1, 2020
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published
July 1, 2020
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Published
June 10, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Published
June 10, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Published
June 10, 2020
Distribution
Nationwide

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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.