Use caution Drug recall · FDA · Published October 11, 2019

X-Gen Recalls Levetiracetam Injection Due to Labeling Errors

X-Gen Pharmaceuticals recalls Levetiracetam Injection vials due to incorrect package inserts. Check lot numbers and expiration dates for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0519-2020Drug X-Gen Pharmaceuticals ›

Use caution until it’s fixed

Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.

Take action

Contact the company

Recalling firmX-Gen Pharmaceuticals Inc.300 Daniel Zenker Dr · Horseheads, NY 14845-1014

✎ GovInfoNow plain-language explainer

X-Gen Pharmaceuticals Inc. is recalling Levetiracetam Injection, 500 mg/5mL, because the wrong package insert was attached to the boxes. This labeling error affects specific lots distributed nationwide in the U.S. The recall involves a total of 25,120 vials. Read more at govinfonow.com/recall/37858-x-gen-recalls-levetiracetam-injection-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/37858-x-gen-recalls-levetiracetam-injection-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0519-2020

Cite this page

“X-Gen Recalls Levetiracetam Injection Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37858-x-gen-recalls-levetiracetam-injection-due-to-labeling-errors. Based on FDA recall #D-0519-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2020%22&limit=1).

The FDA announced on Oct. 11, 2019, that X-Gen Pharmaceuticals Inc. is recalling Levetiracetam Injection due to incorrect or missing package inserts. The recall affects 25,120 vials distributed nationwide.

How to tell if you have it

Brand: X-Gen Pharmaceuticals
Product: Levetiracetam Injection, 500 mg/5mL
Packaging: 10 single-use 5 mL vials
NDC: 39822-4000-1
Lot codes: 7603333, 7603334, 7603335 (Exp 05/2020); 7051107 (Exp 01/2022)
Quantity: 25,120 vials
Distribution: U.S.A. Nationwide

The hazard

The recall is due to labeling issues where an incorrect package insert version was attached to the product.

Context

GovInfoNow's records show X-Gen Pharmaceuticals Inc. has had six other recalls since July 17, 2014. Other recent recalls of similar products include X-Gen Cyclophosphamide Injection (April 2, 2024), X-Gen Neomycin Sulfate Tablets (March 19, 2021), and X-Gen Clonidine Injection (March 29, 2019). Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), Xyvona (Levorphanol) 2mg Tablet (May 22, 2026), and ICU Medical Potassium Chloride Injection (Oct. 29, 2025).

How to tell if you have this one

Look for Levetiracetam Injection, 500 mg/5mL, in 10 single-use 5 mL vials boxes manufactured by Agile Specialties Private Limited for X-Gen Pharmaceuticals Inc. Check for NDC 39822-4000-1 and the following lot numbers: 7603333, 7603334, 7603335 (Expiration 05/2020) or 7051107 (Expiration 01/2022).

Brand
X-Gen Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Inventory
Verify if you have any of the affected lot numbers: 7603333, 7603334, 7603335, or 7051107.
Contact Your Provider
If you have the recalled product, contact your healthcare provider or pharmacist for instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Oct 11, 2019Firm started the recall
Nov 21, 2019FDA classified it Class III
Nov 27, 2019Published in FDA’s Enforcement Report
Aug 16, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37858-x-gen-recalls-levetiracetam-injection-due-to-labeling-errors">X-Gen Recalls Levetiracetam Injection Due to Labeling Errors (GovInfoNow)</a>

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-0519-2020 (October 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0519-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.