Mylan Laboratories Limited, (Nashik FDF)

Complete recall history across all FDA and CPSC categories — 13 total recalls

Mylan Laboratories Limited, (Nashik FDF) 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 (13)

FDA drug safety enforcement actions by Mylan Laboratories Limited, (Nashik FDF)

Date Product Reason Class
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... 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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