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Ranbaxy Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Ranbaxy 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 (9)

FDA drug safety enforcement actions by Ranbaxy Inc.

Date Product Reason Class
Jun 26, 2015 Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Car... Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. ... Class II
Jan 16, 2014 Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma... Presence of Foreign Tablets: A product complaint was received by a pharmacist... Class II
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tub... Crystallization: Recall is due to a non-characteristic gritty/sandy texture t... Class III
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only... Crystallization: Recall is due to a non-characteristic gritty/sandy texture t... Class III
Nov 9, 2012 Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg... Class II
Nov 9, 2012 Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg... Class II
Nov 9, 2012 Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg... Class II
Aug 21, 2012 Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma... Adulterated Presence of Foreign Tablets: A product complaint was received by ... Class II
Mar 16, 2012 Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution,... Subpotent (Single Ingredient Drug): out-of-specification result for coal tar ... 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.

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