FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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

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 23, 2026 at 11:04 PM UTC.

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