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Lupin Limited

Complete recall history across all FDA and CPSC categories — 4 total recalls

Lupin Limited 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 (4)

FDA drug safety enforcement actions by Lupin Limited

Date Product Reason Class
Nov 17, 2017 Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufacture... Presence of foreign tablets/capsules: This product lot is being recalled due ... Class II
Mar 24, 2016 Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:... Labeling: Incorrect or Missing Lot and/or Expiration Date Class III
Feb 19, 2016 Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactu... CGMP Deviations: finished products manufactured using active pharmaceutical i... Class III
Feb 19, 2016 Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactur... CGMP Deviations: finished products manufactured using active pharmaceutical i... Class III

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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