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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
May 25, 2023 Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II Viatris Inc
Feb 1, 2019 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... Defective Container: Potential for broken glass in the neck area of the glass bottles. Class II Mylan Pharmaceuticals Inc.
Oct 17, 2011 Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC indus... Labeling: Presence of Undeclared Color Additive; The product is being recalled because several in... Class II Meda Pharmaceuticals 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.