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Teva North America

Complete recall history across all FDA and CPSC categories — 12 total recalls

Teva North America 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 (12)

FDA drug safety enforcement actions by Teva North America

Date Product Reason Class
Aug 5, 2016 Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... Failed Impurities/Degradation Specifications. Class III
Jul 15, 2016 Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg p... Failed Content Uniformity Specifications: out of specification test result fo... Class III
Jun 24, 2016 Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... Superpotent drug: Out of specification test result for assay during stability... Class II
Jun 22, 2016 Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... Presence of Foreign Substance; presence of black particles describes generica... Class II
Jun 17, 2016 Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... CGMP Deviations Class II
Jun 17, 2016 Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... CGMP Deviations Class II
Jun 17, 2016 Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... CGMP Deviations Class II
Jun 17, 2016 ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... CGMP Deviations Class II
May 31, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: High out of specification resul... Class III
May 18, 2016 Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... Failed Tablet/Capsule Specifications Class III
Apr 27, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... Lack of Assurance of Sterility: Due to potential for leaking bags. Class II
Dec 21, 2015 Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... Failed Dissolution Specifications: low test results at the 18 month time-point 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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