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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 14, 2022 Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag,... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chl... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL ex... Defective container Class II Athenex Pharma Solutions, 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.