Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Levetiracetam Injection Recalled by X-Gen Pharmaceuticals Inc. Due to Labeling: Incorrect or Missing Package Insert - the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact X-Gen Pharmaceuticals Inc. directly.
Affected Products
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
Quantity: 25120 vials
Why Was This Recalled?
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About X-Gen Pharmaceuticals Inc.
X-Gen Pharmaceuticals Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report