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.
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