Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HydrOXYzine Hydrochloride Oral Solution Recalled by Hi-Tech Pharmacal Co., Inc. Due to Failed Impurity/Degradation Specification; out-of-specification result for one individual...
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 Hi-Tech Pharmacal Co., Inc. directly.
Affected Products
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.
Quantity: 451,916 bottles
Why Was This Recalled?
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hi-Tech Pharmacal Co., Inc.
Hi-Tech Pharmacal Co., Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report