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Teva Pharmaceuticals USA Recalls

279 recalls on record · June 27, 2012 to May 13, 2026 · Drugs

Recalls by year

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

March 12, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA,

Hazard: CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

February 12, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech

Hazard: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

February 12, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industrie

Hazard: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

February 12, 2014DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., L

Hazard: Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.

January 29, 2014DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceutica

Hazard: Failed Stability Specifications: this product is below specification for preservative content.

January 8, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA

Hazard: Failed Tablet/Capsule Specifications: There is a potential for broken tablets.

January 8, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufacture

Hazard: Presence of Precipitate; precipitation of drug product

January 1, 2014DrugsFDA

Teva Pharmaceuticals USA recalls Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufac

Hazard: Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.

November 27, 2013DrugsFDA

Teva Pharmaceuticals USA recalls Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syrin

Hazard: Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.

September 11, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-

Hazard: Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

September 4, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Cze

Hazard: Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.

August 14, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA

Hazard: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

August 14, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA

Hazard: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

August 14, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA

Hazard: Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

August 14, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersvil

Hazard: Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

July 24, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73

Hazard: Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratori

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Bar

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regi

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

July 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratorie

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

June 26, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count

Hazard: Failed Dissolution Specification; during stability testing

June 19, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Hazard: Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

June 12, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA

Hazard: CGMP Deviation; cotton coil is missing in some packaged bottles

June 5, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-C

Hazard: Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

June 5, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets

Hazard: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

April 24, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps

Hazard: Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.

April 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-41

Hazard: Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

April 17, 2013DrugsFDA

Teva Pharmaceuticals USA, Inc. recalls Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispense

Hazard: Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.