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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 9 FDA drug recalls.

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DateProductReasonClassFirm
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. 5 in the capsule shell. Class II Ranbaxy Inc.
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 who discovered an A... Class II Ranbaxy Inc.
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 to the product which ... Class III Ranbaxy Inc.
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 to the product which ... Class III Ranbaxy Inc.
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, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
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, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
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, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
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 a pharmacist who dis... Class II Ranbaxy Inc.
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 content assay. Class III Ranbaxy Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.