Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Due to Impurities/Degradation Products: High Out of Specification results for...
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 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals directly.
Affected Products
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
Quantity: 73,746 bottles
Why Was This Recalled?
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report