HYDROXYZINE HYDROCHLORIDE

Generic: HYDROXYZINE HYDROCHLORIDE

ANI PharmaceuticalsManufacturer
ORALRoute
HYDROXYZINE DIHYDROCHLORIDEActive Substance
2025-12-16Original Approval

HYDROXYZINE HYDROCHLORIDE is FDA application ANDA219648, sponsored by NOVITIUM PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-12-11
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an

Class II2018-10-11
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for un

Class II2013-12-11
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940.

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an

Class III2026-06-02
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,

Presence of foreign substance

Class II2013-12-11
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940.

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an

Top Reported Reactions

1
PRURITUS
3,235 reports
2
DRUG INEFFECTIVE
3,221 reports
3
NAUSEA
2,855 reports
4
FATIGUE
2,764 reports
5
TOXICITY TO VARIOUS AGENTS
2,502 reports
6
OFF LABEL USE
2,475 reports
7
PAIN
2,333 reports
8
HEADACHE
2,302 reports
9
COMPLETED SUICIDE
2,238 reports
10
RASH
2,143 reports