Class III โ€” Low Risk

Low risk โ€” 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: The side...

Date: July 17, 2014
Company: X-Gen Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

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/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.

Quantity: 8,356 vials

Why Was This Recalled?

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About X-Gen Pharmaceuticals Inc.

X-Gen Pharmaceuticals Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report