Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vardenafil HCl Recalled by Kalchem International, Inc. Due to cGMP Deviations: Lack of stability data and controls...

Date: February 19, 2018
Company: Kalchem International, 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 Kalchem International, Inc. directly.

Affected Products

Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05

Quantity: 500 gram jar

Why Was This Recalled?

cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About Kalchem International, Inc.

Kalchem International, Inc. has 1 total recall tracked by RecallDetector.

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