⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ANI Pharmaceuticals, Inc.: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN

DrugsSource: FDA (drug) · Date: 2026-07-01

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
ANI Pharmaceuticals, Inc.
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 / hazard
Presence of foreign substance
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-06-02
Code info
Lot S25133A
Product quantity
6564 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Baudette
State
MN
Country
United States
Event id
99131
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