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.

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution Recalled by Lannett Company, Inc. Due to CGMP Deviations: cleaning procedures during manufacturing caused out...

Date: October 11, 2018
Company: Lannett Company, 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 Lannett Company, Inc. directly.

Affected Products

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.

Quantity: 8,324 bottles

Why Was This Recalled?

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Lannett Company, Inc.

Lannett Company, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

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