Teva Pharmaceuticals USA, Inc.

Complete recall history across all FDA and CPSC categories — 33 total recalls

Teva Pharmaceuticals USA, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (33)

FDA drug safety enforcement actions by Teva Pharmaceuticals USA, Inc.

Date Product Reason Class
Nov 4, 2019 Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... Presence of foreign substance: Brown/black particles found during stability t... Class II
Nov 14, 2013 Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L... Failed Stability Specifications: this product is below specification for pres... Class III
Nov 8, 2013 Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufacture... Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragmen... Class II
Aug 13, 2013 CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medic... Lack of Assurance of Sterility: The required reduction of endotoxin was not m... Class II
Aug 6, 2013 Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, ... Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propan... Class II
Jul 23, 2013 Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactur... Labeling -label error on declared strength: unopened, sealed bottle of Terazo... Class II
Jun 18, 2013 Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-41... Discoloration: This recall is being carried out due to an orange to brown di... Class III
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of sp... Class II
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of sp... Class II
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of sp... Class II
May 28, 2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin... Failed Dissolution Specification; during stability testing Class II
Apr 26, 2013 Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0... Discoloration: This recall is being carried out due to a yellow to brown disc... Class III
Mar 19, 2013 Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T... CGMP Deviation; cotton coil is missing in some packaged bottles Class III
Mar 15, 2013 Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 m... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 15, 2013 Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 9... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 15, 2013 Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 ... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 15, 2013 Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 15, 2013 Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 15, 2013 Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 t... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 14, 2013 Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and E... Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl... Class III
Mar 14, 2013 Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 e... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-... Class III
Mar 12, 2013 Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, ... Failed Tablet/Capsule Specifications: This recall is being carried out due to... Class III
Mar 12, 2013 Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count... Failed Tablet/Capsule Specifications: This recall is being carried out due to... Class III
Feb 26, 2013 Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0... Defective Container: This recall is being carried out due to the potential fo... Class II
Feb 7, 2013 CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blist... Failed Content Uniformity Specifications: Recall is being carried out due to ... Class II
Jan 23, 2013 Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC... Presence of Foreign Tablets/Capsules: Recall is being conducted due to a fore... Class II
Dec 5, 2012 Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single us... Presence of Foreign Substance: Product is being recalled due to receiving an ... Class II
May 18, 2012 Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed b... Presence of Foreign Substance: Recall is being initiated due to the presence ... Class II
May 16, 2012 Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactur... Tablet Thickness: Potential for some tablets not conforming to weight specifi... Class II
May 2, 2012 Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.... Impurities/Degradation: This recall is being carried out due to the potentia... Class II
Apr 24, 2012 CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA... Impurities/Degradation Products: This lot of product will not meet the impuri... Class III
Apr 23, 2012 Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each... Contraceptive Tablets Out of Sequence: This recall has been initiated due to ... Class III
Apr 2, 2012 Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs p... Tablet Thickness: Product is being recalled due to the potential of being und... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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