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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 I

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Published
September 2, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Published
July 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: OOS result during stability testing
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Published
June 3, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Published
May 6, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Published
May 6, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Published
August 20, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

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

Kariva (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, Sellersville, PA NDC 0555-9050-58

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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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.