Hydroxyzine recalls
The FDA has published 16 recalls involving Hydroxyzine since 2012. The latest was reported on 1 Jul 2026. Most were for potency & assay. Kvk-Tech has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 16 since 2012
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 1 latest 1 Jul 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%12 75%4 25%
Why hydroxyzine is recalled
Ongoing hydroxyzine recalls 1 active
All hydroxyzine recalls, newest first 16 total Reported Class Recall Company Reason Where 1 Jul 2026 Drug CLASS III hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalled Hydroxyzine Hydrochloride ANI Pharmaceuticals Other Nationwide 30 Dec 2020 Drug CLASS II Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled Morton Grove Pharmaceuticals Potency & Assay Nationwide 31 Oct 2018 Drug CLASS II HydrOXYzine Hydrochloride Syrup recalled by Lannett Company Hydroxyzine Hydrochloride Lannett Potency & Assay Nationwide 5 Oct 2016 Drug CLASS II Hydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalled Pharmacy Plus Sterility MS 22 Jul 2015 Drug CLASS III HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled Qualitest Pharmaceuticals Other Nationwide 17 Jun 2015 Drug CLASS II Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn Akorn Potency & Assay Nationwide 17 Jun 2015 Drug CLASS II Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn Akorn Potency & Assay Nationwide 5 Nov 2014 Drug CLASS II HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled Hi-Tech Pharmacal Potency & Assay Nationwide 5 Nov 2014 Drug CLASS II Hydroxyzine hydrochloride 25 mg/mL injectable recalled Martin Avenue Pharmacy Sterility Nationwide 9 Apr 2014 Drug CLASS II HydrOXYzine HCl Tablets, USP 50 mg Blister recalled American Health Packaging Manufacturing (CGMP) Deviations Nationwide 9 Apr 2014 Drug CLASS II HydrOXYzine HCl Tablets, USP 25 mg Blister recalled American Health Packaging Manufacturing (CGMP) Deviations Nationwide 29 Jan 2014 Drug CLASS II HydrOXYzine HCI Tablets USP 50 mg recalled by KVK-Tech Hydroxyzine Hydrochloride Kvk-Tech Manufacturing (CGMP) Deviations Nationwide 29 Jan 2014 Drug CLASS II HydrOXYzine HCI Tablets USP 25 mg recalled by KVK-Tech Hydroxyzine Hydrochloride Kvk-Tech Manufacturing (CGMP) Deviations Nationwide 29 Jan 2014 Drug CLASS II HydrOXYzine HCI Tablets USP 10 mg recalled by KVK-Tech Hydroxyzine Hydrochloride Kvk-Tech Manufacturing (CGMP) Deviations Nationwide 26 Jun 2013 Drug CLASS III HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled Hi-Tech Pharmacal Potency & Assay Nationwide 25 Jul 2012 Drug CLASS III Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/, 1 Pint recalled Vintage Pharmaceuticals Potency & Assay Nationwide
Should you stop taking Hydroxyzine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.