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
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Terminated
Historical record Class III
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15 by Teva Pharmaceuticals USA
Reason
Failed Moisture Limits: out of specification test results for water content obtained during stability testing. Published
August 16, 2017 Distribution
Product distributed to OH, IL, PA, MI, V…
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FDA Recall
Terminated
Historical record Class II
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60 by Teva Pharmaceuticals USA
Reason
Failed Tablet/Capsule Specification; out of specification for tablet weight Published
August 9, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: high out of specification results for related compound D. Published
August 9, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56 by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. Published
July 26, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56 by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. Published
July 26, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel by Teva Pharmaceuticals USA
Reason
Microbial Contamination of Non-Sterile Products Published
May 17, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87 by Teva Pharmaceuticals USA
Reason
Failed Stability Specifications Published
May 17, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56 by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications Published
March 22, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. by Teva Pharmaceuticals USA
Reason
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. Published
March 15, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. Published
February 22, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73 by Teva Pharmaceuticals USA
Reason
Subpotency: due to a low, out of specification test result for assay during stability testing. Published
February 1, 2017 Distribution
United States and Puerto Rico
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FDA Recall
Terminated
Historical record Class III
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. by Teva Pharmaceuticals USA
Reason
Failed Dissolution Specifications Published
January 25, 2017 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.
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