Hydroxyzine Hydrochloride Oral Solution (Vintage Pharmaceuticals) – impurity risk (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Lot Codes / Batch Numbers
Lot #s: L030F11A, L054F11A, Exp 05/13, L095E10A, Exp 06/13, L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13, L094L10A, Exp 12/13, and L100L10B, Exp 01/14
Products Sold
Lot #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals is recalling HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: due to Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026