Hydroxyzine recalls

The FDA has published 12 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 recalls12since 2012

Last 12 months1reported

Class I00% of total

Ongoing1latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 0 0%Class II 8 67%Class III 4 33%

Why hydroxyzine is recalled

Companies

By year

202618%
202018%
201818%
201518%
2014650%
201318%
201218%

Ongoing hydroxyzine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide

All hydroxyzine recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
30 Dec 2020Drug	CLASS II	Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled	Morton Grove Pharmaceuticals	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride	Lannett Company	Potency & Assay	Nationwide
22 Jul 2015Drug	CLASS III	HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled	Qualitest Pharmaceuticals	Other	Nationwide
5 Nov 2014Drug	CLASS II	HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled	Hi-Tech Pharmacal Co	Potency & Assay	Nationwide
9 Apr 2014Drug	CLASS II	HydrOXYzine HCl Tablets, USP 50 mg Blister recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
9 Apr 2014Drug	CLASS II	HydrOXYzine HCl Tablets, USP 25 mg Blister recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
29 Jan 2014Drug	CLASS II	HydrOXYzine HCI Tablets USP 50 mg recalled by KVK-TechHydroxyzine Hydrochloride	KVK-Tech	Manufacturing (CGMP) Deviations	Nationwide
29 Jan 2014Drug	CLASS II	HydrOXYzine HCI Tablets USP 25 mg recalled by KVK-TechHydroxyzine Hydrochloride	KVK-Tech	Manufacturing (CGMP) Deviations	Nationwide
29 Jan 2014Drug	CLASS II	HydrOXYzine HCI Tablets USP 10 mg recalled by KVK-TechHydroxyzine Hydrochloride	KVK-Tech	Manufacturing (CGMP) Deviations	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.