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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

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Published
July 2, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY

by Teva Pharmaceuticals USA

Reason
Non-sterility: due to a failed sterility test
Published
June 4, 2014
Distribution
NY and KY

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FDA Recall Terminated Historical recordClass II

QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.

by Teva Pharmaceuticals USA

Reason
Defective Delivery System; defective valve
Published
May 28, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Published
May 28, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Published
May 28, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Published
May 21, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Published
May 21, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Published
May 21, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Published
May 21, 2014
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.