Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Nov 14, 2024 Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 m... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 ... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Glut... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 m... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 o... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net C... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (2... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manu... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Oct 17, 2024 Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Onl... Subpotent Drug Class II Keystone Industries

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.