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

Phenytoin Sodium Injection Recalled Due to Missing Vial Label Barcode

Acella Pharmaceuticals is recalling Phenytoin Sodium Injection (250 mg/5 mL) due to missing barcodes on vial labels. Affected product was distributed nationwide; consumers should verify lot numbers and contact the manufacturer.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall for a labeling defect—specifically missing barcodes on vial labels. No illnesses or injuries have been reported. Per the severity rubric, minor labeling errors without safety hazards are classified as Moderate (Score 2).

Plain-English summary

Acella Pharmaceuticals, LLC is recalling Phenytoin Sodium Injection, USP, 250 mg/5 mL (NDC 42192-614-05), due to missing barcodes on the primary vial labels. A total of 637 cartons containing Lot E026A001 (expiration 06/2023) were distributed nationwide in the United States.

The recall was initiated based on customer complaints that the vial labels were missing barcodes. This labeling defect may affect proper product identification and tracking in healthcare settings.

Healthcare providers and patients who have received or are in possession of affected product should verify the lot number E026A001 and contact Acella Pharmaceuticals for further guidance on this product.

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