X-Gen Pharmaceuticals Inc. recalls Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private
X-Gen Pharmaceuticals recalls Levetiracetam injection vials with incorrect package inserts. This may cause confusion about proper use. Contact for details.
Lower-risk recall
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Contact the company & request your remedy
What happened, in plain English
X-Gen Pharmaceuticals is recalling Levetiracetam injection vials that have incorrect or missing package inserts. This could lead to confusion about how to use the medication properly. Read more at govinfonow.com/recall/37858-x-gen-levetiracetam-injection-recall-incorrect-package-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/37858-x-gen-levetiracetam-injection-recall-incorrect-package-insert · Updated October 5, 2026 · FDA enforcement record: FDA #D-0519-2020
Cite this page
“X-Gen Levetiracetam Injection Recall: Incorrect Package Insert.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37858-x-gen-levetiracetam-injection-recall-incorrect-package-insert. Based on FDA recall #D-0519-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2020%22&limit=1).
Why it’s dangerous
The package insert is critical for understanding how to safely use the medication. Incorrect or missing inserts could lead to confusion about dosage or administration.
Who’s affected
Prescription patients who received Levetiracetam injection vials with incorrect package inserts. Those using the product without proper instructions may be at higher risk.
How to tell if you have this one
Check for vials with NDC 39822-400: 7603333, 7603334, 7603335 (expiring May 2020) or 7051107 (expiring January 2022). The product is prescription-only and sold in 10 single-use vials.
- Brand
X-Gen Pharmaceuticals- Category
Drug
What to do — step by step
Check Package Insert
Verify if the package insert is correct by checking for the label version number on the vial.
Questions people ask
Is this product safe to use?
The product is safe to use if the package insert is correct. Incorrect inserts may cause confusion about proper use.
What should I do if I have the recalled product?
The official recall notice does not specify a remedy for this issue. Check with your healthcare provider for guidance.
How can I tell if I have the recalled product?
Look for vials with NDC 39822-4000-1 and lot numbers 7603333, 7603334, 7603335 (expiring May 2020) or 7051107 (expiring January 2022).
Contact X-Gen Pharmaceuticals
We’ve drafted a message you can send X-Gen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0519-2020 — X-Gen Pharmaceuticals X-Gen Pharmaceuticals Hello, I own a X-Gen Pharmaceuticals that is covered by recall D-0519-2020 from X-Gen Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-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 qwen3:4b on October 5, 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.