Hydroxyzine Hydrochloride recalls

Hydroxyzine Hydrochloride products have been recalled 5 times, most recently on 1 Jul 2026. The recalling company is usually KVK-Tech. The most common reason is manufacturing (cgmp) deviations.

Total recalls5since 2014

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 4 80%Class III 1 20%

Why hydroxyzine hydrochloride is recalled

Companies

Product types

Anxiety & Sleep Medication5100%

By year

2026120%
2018120%
2014360%

Ongoing hydroxyzine hydrochloride 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 hydrochloride recalls, newest first

5 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
31 Oct 2018Drug	CLASS II	HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride	Lannett Company	Potency & Assay	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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.