Levetiracetam Injection (X-Gen) – Incorrect Labeling (2019)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Brand
X-Gen Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #: 7603333, 7603334, 7603335, Exp 05/2020, 7051107, Exp 01/2022
Products Sold
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
X-Gen Pharmaceuticals Inc. is recalling Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Speci due to Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026