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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Mar 9, 2012 Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufact... Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is... Class III Pack Pharmaceuticals

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.