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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

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

by Teva Pharmaceuticals USA

Reason
Mislabeling
Published
February 9, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28

by Teva Pharmaceuticals USA

Reason
Mislabeling
Published
February 9, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Published
February 9, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Published
February 9, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Published
January 26, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
January 19, 2022
Distribution
Methylprednisolone, TN Norepinephrine BI…

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FDA Recall Terminated Historical recordClass II

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
January 19, 2022
Distribution
Methylprednisolone, TN Norepinephrine BI…

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FDA Recall Terminated Historical recordClass II

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

by Teva Pharmaceuticals USA

Reason
Subpotent
Published
December 29, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications
Published
November 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90

by Teva Pharmaceuticals USA

Reason
Labelling: Incorrect Exp. Date
Published
November 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

by Teva Pharmaceuticals USA

Reason
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.

by Teva Pharmaceuticals USA

Reason
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Published
October 27, 2021
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.