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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
Jul 21, 2023 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... CGMP deviation: product released prior to supplier approval. Class II The Ritedose Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
Apr 1, 2022 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... Class III The Ritedose Corporation
Jan 26, 2022 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE

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.