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Teva Pharmaceuticals USA Recalls
279 recalls on record · June 27, 2012 to May 13, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 8, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count
Hazard: Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
November 1, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc.
Hazard: Failed Dissolution Specifications: Low out of specification results for dissolution.
October 4, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malt
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
August 16, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx onl
Hazard: Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
August 9, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA
Hazard: Failed Tablet/Capsule Specification; out of specification for tablet weight
August 9, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials Fo
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
July 26, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuti
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
July 26, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmace
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
May 17, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose B
Hazard: Microbial Contamination of Non-Sterile Products
May 17, 2017DrugsFDA
Teva Pharmaceuticals USA recalls PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By:
Hazard: Failed Stability Specifications
March 22, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTI
Hazard: Failed Impurities/Degradation Specifications
March 15, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 b
Hazard: Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
February 22, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-1
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
February 1, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARM
Hazard: Subpotency: due to a low, out of specification test result for assay during stability testing.
January 25, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 b
Hazard: Failed Dissolution Specifications
December 14, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory,
Hazard: Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
December 14, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory,
Hazard: Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
October 26, 2016DrugsFDA
Teva Pharmaceuticals USA recalls PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
October 26, 2016DrugsFDA
Teva Pharmaceuticals USA recalls PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
October 26, 2016DrugsFDA
Teva Pharmaceuticals USA recalls PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet
Hazard: Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
October 19, 2016DrugsFDA
Teva Pharmaceuticals USA recalls mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medi
Hazard: Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
October 19, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, I
Hazard: CGMP Deviations
October 19, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA,
Hazard: CGMP Deviations
June 1, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceutica
Hazard: Presence of Particulate Matter: particulate matter identified as glass in one vial.
March 23, 2016DrugsFDA
Teva Pharmaceuticals USA recalls Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt V
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
March 23, 2016DrugsFDA
Teva Pharmaceuticals USA recalls NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Hazard: Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
January 20, 2016DrugsFDA
Teva Pharmaceuticals USA recalls DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Sa
Hazard: Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
September 2, 2015DrugsFDA
Teva Pharmaceuticals USA recalls ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by T
Hazard: Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
August 12, 2015DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 1
Hazard: Failed Impurities/Degradation Specifications: out of specification for unknown impurity
July 15, 2015DrugsFDA
Teva Pharmaceuticals USA recalls Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intraven
Hazard: Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.