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FDAJune 2, 2026drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of foreign substance

What to do

FDA enforcement status: Ongoing

Brands named

ani pharmaceuticalsani

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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