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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Aug 21, 2015 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa... Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling pr... Class II Nephron Pharmaceuticals Corp.
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Race... Discoloration Class II Nephron Pharmaceuticals Corp.
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (... Discoloration Class II Nephron Pharmaceuticals Corp.
Oct 2, 2013 Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalatio... Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic ... Class II Nephron Pharmaceuticals Corp.
Jun 22, 2011 Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose ... Lack of Assurance of Sterility Class II Nephron Pharmaceuticals Corp.

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.