The Recall Desk
LowFDA (Drugs)·D-0070-2023·Announced 2022-11-30

Phenytoin Sodium Injection recalled for missing barcodes on vial labels

Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect—specifically, a missing barcode on the vial label. The hazard is a packaging and documentation issue, not a product safety concern.

Plain-English summary

Acella Pharmaceuticals, LLC is recalling Phenytoin Sodium Injection, USP 250 mg/5 mL due to customer complaints that the primary vial label is missing a barcode. The affected lot is E026A001 with an expiration date of 06/2023, consisting of 637 cartons distributed nationwide throughout the United States.

Patients and healthcare providers who have received this product should verify the lot number against the recall information. For questions about the recall or affected product, contact Acella Pharmaceuticals, LLC.

The recalled product

Product
PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Brand
PHENYTOIN SODIUM
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug
Hazard
  • mis-labeling

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 (1)

  • Lot: E026A001 Exp. 06/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PHENYTOIN SODIUM

Same category