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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jul 15, 2022 Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) ... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) ... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) pe... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America 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.