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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
Aug 11, 2023 Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... Class II AVKARE LLC
Aug 11, 2023 Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... Class II AVKARE LLC
Jun 13, 2023 Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III AVKARE LLC
Dec 22, 2022 Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Onl... Failed impurities/degradation specifications: Out of specification for unknown impurities. Class II AVKARE LLC

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.