Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fosphenytoin Sodium Injection Recalled by West-ward Pharmaceutical Corp. Due to Presence of Particulate Matter: This product is being...
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 West-ward Pharmaceutical Corp. directly.
Affected Products
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Quantity: a) 74,960 vials; b) 911,070 vials
Why Was This Recalled?
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Where Was This Sold?
All lots were distributed throughout the US.
About West-ward Pharmaceutical Corp.
West-ward Pharmaceutical Corp. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report