Hydroxyzine Hydrochloride: 5 recalls on record

Recalled by 1 agency: FDA (5).

First recall on record: January 29, 2014. Most recent: July 1, 2026.

Risk classification: Class II: 4 · Class III: 1

Most recent recalls

DateAgencyProduct
July 1, 2026FDAhydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distr…D-0619-2026
October 31, 2018FDAHydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg pe…D-0083-2019
January 29, 2014FDAHydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK…D-1032-2014
January 29, 2014FDAHydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KV…D-1031-2014
January 29, 2014FDAHydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newt…D-1030-2014

Questions about this brand

How many recalls does Hydroxyzine Hydrochloride have?
Recalert has 5 U.S. recalls on record for Hydroxyzine Hydrochloride, published between January 29, 2014 and July 1, 2026.
What was the most recent Hydroxyzine Hydrochloride recall?
FDA recall D-0619-2026, published July 1, 2026: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Which agencies have recalled Hydroxyzine Hydrochloride products?
Hydroxyzine Hydrochloride products appear in recalls from: FDA (5).

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