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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Jul 5, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Class II FDC Limited
Apr 18, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Mar 11, 2025 Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles,... Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Jan 23, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Dec 16, 2024 Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL... Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Dec 5, 2024 Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx onl... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Oct 29, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Aug 12, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (ND... Defective Container: patients are unable to get the solution out of the bottle as the spike of th... Class II FDC Limited
Jul 23, 2024 Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 1... Defective container: unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Jul 18, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective container; yellow colored spike from cap lodged in the nozzle Class II FDC Limited
Apr 25, 2024 Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... Class II FDC Limited
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising 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.