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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
Mar 13, 2020 *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated
Aug 17, 2015 Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... Class I Hartley Medical Center Pharmacy, Incorporated

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.