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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2025 Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... CGMP Deviations Class II CA BOTANA International, 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.