Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
HydrOXYzine Hydrochloride Oral Solution Recalled by Hi-Tech Pharmacal Co., Inc. Due to Subpotent; 24 month stability test station
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/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Quantity: lot 608917: 7764 bottles; lot 608204: 7476 bottles
Why Was This Recalled?
Subpotent; 24 month 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