Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution Recalled by Qualitest Pharmaceuticals Due to Failed impurities/degradation specifications; out of specification for the...
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
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Quantity: 438,055 bottles
Why Was This Recalled?
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qualitest Pharmaceuticals
Qualitest Pharmaceuticals has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report