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Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Mar 3, 2026 STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and t... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (1... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), S... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. 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.