Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells phar... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg pe... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... cGMP deviations. Class II Wells Pharma of Houston LLC
Nov 22, 2023 ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... Lack of assurance of sterility. Class II Wells Pharma of Houston LLC

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.