Data Composite

Recall D-0619-2026

US Class III Ongoing · initiated 2026-06-02

Recalling firm

ANI Pharmaceuticals, Inc., MN

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

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