Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fomepizole Injection Recalled by Navinta LLC Due to Lack of Assurance of Sterility. A recent FDA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Navinta LLC directly.
Affected Products
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
Quantity: 14,628 units
Why Was This Recalled?
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Navinta LLC
Navinta LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report