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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 II

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Published
November 21, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

by Teva Pharmaceuticals USA

Reason
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Published
October 31, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

by Teva Pharmaceuticals USA

Reason
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Published
October 31, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Published
October 24, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

by Teva Pharmaceuticals USA

Reason
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Published
October 10, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

by Teva Pharmaceuticals USA

Reason
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Published
August 15, 2018
Distribution
Product was distributed throughout the U…

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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.