Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

HydrOXYzine Hydrochloride Tablets Recalled by Qualitest Pharmaceuticals Due to Failed Tablet/Capsule Specifications; The identification codes on some...

Date: June 29, 2015
Company: Qualitest Pharmaceuticals
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 Qualitest Pharmaceuticals directly.

Affected Products

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

Quantity: 47,376 bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Qualitest Pharmaceuticals

Qualitest Pharmaceuticals has 16 total recalls tracked by RecallDetector.

Related Recalls

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