Acella Pharmaceuticals Phenytoin Sodium Injection Recall: Missing Barcode Label
Acella Pharmaceuticals recalls Phenytoin Sodium Injection (250 mg/5 mL) due to missing barcode on primary vial labels. This affects patients using the product for seizures. Contact the manufacturer for details.
Lower-risk recall
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Contact the company
What happened, in plain English
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection vials because the primary vial label may be missing a barcode. This issue does not pose a safety risk but could cause problems with product identification and dispensing. Read more at govinfonow.com/recall/34223-acella-pharmaceuticals-phenytoin-sodium-injection-recall-missing-barcode-label.
Source Summary by GovInfoNow · govinfonow.com/recall/34223-acella-pharmaceuticals-phenytoin-sodium-injection-recall-missing-barcode-label · Updated August 18, 2026 · FDA enforcement record: FDA #D-0070-2023
Cite this page
“Acella Pharmaceuticals Phenytoin Sodium Injection Recall: Missing Barcode Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34223-acella-pharmaceuticals-phenytoin-sodium-injection-recall-missing-barcode-label. Based on FDA recall #D-0070-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2023%22&limit=1).
Why it’s dangerous
The missing barcode on the primary vial label can make it difficult to identify the product correctly. This may lead to errors in dispensing or tracking the medication, but it does not pose a direct safety risk to the patient.
Who’s affected
Patients prescribed Phenytoin Sodium Injection for seizures. Those using the product without a clear label may face difficulties with proper identification and dispensing.
How to tell if you have this one
Check for vials labeled 'Phenytoin Sodium Injection, USP, 250 mg/5 mL' with NDC 42192-614-05, packaged in 10 vials per carton. The product is prescription-only and manufactured by Acella Pharmaceuticals.
- Brand
Acella Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0069-2023 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005; Lot: E025A001 Exp. 07/2023 | 574 cartons | 42192-614-10, 42192-614-30, 42192-614-02 |
| D-0070-2023 | 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; Lot: E026A001 Exp. 06/2023 | 637 cartons | 42192-614-10, 42192-614-30, 42192-614-05 |
What to do — step by step
Check Label
Verify if the primary vial label has a barcode. If missing, do not use the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0070-2023 (November 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0070-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.