Teva Pharmaceuticals USA Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2018 12 2019 6 2020 22 2021 53 2022 7
Download CSV FDA Recall
Terminated
Historical record Class III
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13. by Teva Pharmaceuticals USA
Reason
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. Published
December 14, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples). by Teva Pharmaceuticals USA
Reason
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. Published
December 14, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Published
October 26, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Published
October 26, 2016 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class III
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Published
October 26, 2016 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials). by Teva Pharmaceuticals USA
Reason
CGMP Deviations Published
October 19, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. Published
October 19, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials). by Teva Pharmaceuticals USA
Reason
CGMP Deviations Published
October 19, 2016 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class I
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03 by Teva Pharmaceuticals USA
Reason
Presence of Particulate Matter: particulate matter identified as glass in one vial. Published
June 1, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing. Published
March 23, 2016 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class III
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL by Teva Pharmaceuticals USA
Reason
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Published
March 23, 2016 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. Published
January 20, 2016 Distribution
Nationwide
View recall →
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.
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