Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Clonidine HCL Injection Recalled by X-Gen Pharmaceuticals Inc. Due to Labeling: Label Error on Declared Strength: Side carton...
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
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Quantity: 24,966 vials
Why Was This Recalled?
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
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