FDA recall D-0619-2026

Product

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

Reason for recall

Presence of foreign substance

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-06-02

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baudette, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2026