FDAClass III · Drug · Recalled July 1, 2026

hydrOXYzine Hydrochloride Oral Solution recall — ANI Pharmaceuticals, Inc.

Hazard: Presence of foreign substance

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0619-2026
Brand: ANI Pharmaceuticals
Classification: Class III
Units affected: 6564 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

hydrOXYzine Hydrochloride Oral Solution

Companies & origin

Recalling firm location: Baudette, MN, United States
Firm address: 210 W Main St, N/A, 56623-2467

Identifying details (verbatim from the notice)

Product codes / lots: Lot S25133A
Distribution: Nationwide in the USA
Firm notified the public via: Letter
FDA event ID: 99131
Recall initiated: June 2, 2026
FDA classified: June 24, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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