Caraco Pharmaceutical Laboratories, Ltd.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Caraco Pharmaceutical Laboratories, Ltd. 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 (10)

FDA drug safety enforcement actions by Caraco Pharmaceutical Laboratories, Ltd.

Date Product Reason Class
Jun 26, 2014 Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufact... Class II
Jun 26, 2014 Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufact... Class II
Jun 12, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged... Failed Dissolution Specifications: Stability results found the product did no... Class II
Apr 9, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, ... Lack of Assurance of Sterility: A particle excursion for a different batch of... Class II
Apr 9, 2014 Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Apr 9, 2014 Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufac... Failed Impurities/Degradation Specifications: out of specification results fo... Class III
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... Failed Dissolution Specifications: Stability results found the product did no... Class II
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... Failed Dissolution Specifications: Stability results found the product did no... Class II
Jan 28, 2014 Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bott... Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin ... Class II
Nov 5, 2012 traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Man... Adulterated Presence of Foreign Tablets: A customer complaint was received th... 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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