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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Sep 27, 2016 Amphibious Trauma Kit - Product Code 85-0639, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit - Product Code 85-1274, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-03... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Aid Backpack Kit - Product Code 85-0917, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 USCG Boat Response Kit - Product Code 80-0353, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North America... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue LLC.
Sep 27, 2016 Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744... Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa... Class II North American Rescue 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.