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.

children's allergy (cetirizine hydrochloride) Oral Solution Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Failed Impurities/Degradation Specifications: unknown impurity higher than the...

Date: October 19, 2018
Company: Taro Pharmaceuticals U.S.A., 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 Taro Pharmaceuticals U.S.A., Inc. directly.

Affected Products

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.

Quantity: 8328 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Taro Pharmaceuticals U.S.A., Inc.

Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.

Related Recalls

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