FDAFDA · Food and drugs·Recall number D-0619-2026
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
Published July 1, 2026 · Recall initiated: June 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of foreign substance
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0370954912101
- Lot
- Lot S25133A
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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