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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Oct 27, 2015 Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topic... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-3... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) ,... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx ... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Jun 5, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... CGMP Deviation: Poor container closure of the bulk storage container Class III Geritrex Corp

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.