Class IIIOngoing

hydrOXYzine Hydrochloride Oral Solution recall

FDA recall D-0619-2026 · initiated Jun 2, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 1, 2026How we research

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Presence of foreign substance

Details

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
Recalling company: Ani Pharms Inc
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jun 2, 2026
FDA report date: Jul 1, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0619-2026 ↗

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