Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Nov 16, 2018 BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, ... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3c... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per fil... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, 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.