Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Phenytoin Sodium Injection Recalled by Acella Pharmaceuticals, LLC Due to Labeling: Not elsewhere classified; the 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 Acella Pharmaceuticals, LLC directly.
Affected Products
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Quantity: 637 cartons
Why Was This Recalled?
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Acella Pharmaceuticals, LLC
Acella Pharmaceuticals, LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report