Navinta Recalls Fomepizole Injection Due to Sterility Assurance Concerns
Navinta LLC is recalling Fomepizole Injection due to FDA inspection findings of GMP violations that may impact sterility. The recall covers 14,628 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable product where sterility assurance is compromised, posing a significant risk of infection or adverse health consequences.
Plain-English summary
Navinta LLC is recalling Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), for intravenous infusion. The recall involves 14,628 units distributed nationwide. The affected lots are VFMA 029, VFMA 030, VFMA 031, and VFMA 032 (expiration 4/15), VFMA 033 (expiration 7/2016), and VFMA 034 (expiration 10/2017). The product is manufactured by Emcure Pharmaceuticals Lt. for Sandoz Inc.
The recall was initiated following a recent FDA inspection that reported Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should discontinue use of the affected lots. Consumers and healthcare facilities should contact Navinta LLC or their supplier for instructions on returning the product. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- 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
- Manufacturer
- Navinta LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 14,628
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: VFMA 029
- VFMA 030
- VFMA 031
- VFMA 032 Exp 4/15
- VFMA 033
- Exp 7/2016
- VFMA 034
- Exp 10/2017.
Distribution
Distributed nationwide across the United States.
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