Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HydrOXYzine HCI Tablets USP 50 mg Recalled by KVK-Tech, Inc. Due to Good Manufacturing Practices Deviations: The product has an...
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 KVK-Tech, Inc. directly.
Affected Products
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
Quantity: 104551 bottles
Why Was This Recalled?
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About KVK-Tech, Inc.
KVK-Tech, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report