Phenytoin Sodium Injection Recalled for Missing Vial Barcode
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 (missing barcode) with no reported adverse health consequences. The hazard is administrative/documentary in nature, meeting the criteria for Low severity.
Plain-English summary
Acella Pharmaceuticals, LLC is recalling Phenytoin Sodium Injection, USP, 250 mg/5 mL (Lot E026A001, Exp. 06/2023) due to a labeling defect. The primary vial label on affected units is missing a barcode, which was reported by customers.
The recalled product was distributed nationwide in the USA. A total of 637 cartons were affected. The product is a prescription injection administered by intramuscular or intravenous route.
Healthcare providers and patients who have received this product should check their vials. If you have questions about whether your supply is affected or about obtaining replacement product, contact Acella Pharmaceuticals, LLC.
The recalled product
- Product
- PHENYTOIN SODIUM (PHENYTOIN SODIUM)
- Brand
- PHENYTOIN SODIUM
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug — Injection / Injectable
- Hazard
- Affected units
- 637
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.
Part of a larger recall action
This product is one of 2 recalled by Acella Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · PHENYTOIN SODIUM
- LowPhenytoin Sodium Injection Recalled for Missing Barcode on Vial Label
FDA (Drugs) · 2022-11-30
Same manufacturer · Acella Pharmaceuticals, LLC
See all →- SevereNaproxen Oral Suspension Recalled for Lead and Lithium Contamination
FDA (Drugs) · 2026-05-13
- ModerateDoxycycline hyclate tablets recalled after stability testing failed dissolution specifications
FDA (Drugs) · 2025-10-15
- ModeratePrescription skin cleanser recalled nationwide due to subpotency
FDA (Drugs) · 2024-05-15
- ModerateAcella Recalls Sodium Sulfacetamide Cleansing Pads for Subpotency
FDA (Drugs) · 2022-12-07
- SevereAcella Recalls Subpotent NP Thyroid 15 Tablets Nationwide
FDA (Drugs) · 2021-06-02
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- SevereFresenius Kabi Recalls Fosphenytoin Sodium Injection Due to Glass Particulates
FDA (Drugs) · 2014-07-16
- ModerateAidapak Recalls Phenytoin Sodium ER Capsules Due to Labeling Error
FDA (Drugs) · 2014-01-29
- HighPrescription Drug Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2023-11-15
- ModerateAstellas Recalls Mycamine Injection Vials Due to Labeling Error
FDA (Drugs) · 2018-02-14
- ModerateAmneal Recalls Extended Phenytoin Sodium Capsules Due to Dissolution Failure
FDA (Drugs) · 2013-11-13
- SevereAmneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
FDA (Drugs) · 2017-11-22