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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
Feb 12, 2016 Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, A... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only,... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bo... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N ... Lack of Assurance of Sterility Class II Walter's Pharmacy

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.