Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ibuprofen Lysine Injection Recalled by X-Gen Pharmaceuticals Inc. Due to Presence of Particulate Matter
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
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Quantity: 2593 cartons
Why Was This Recalled?
Presence of Particulate Matter
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