Reported Jul 1, 2026 · Ongoing · Updated Sep 16, 2026
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI…
ANI Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ANI Pharmaceuticals, Inc. · 210 W Main St · Baudette, MN · 56623-2467
Is this the product you have?
- hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only
- Distributed byANI Pharmaceuticals, Inc., Baudette, MN 56623
- NDC70954-912-10
- Lot codes and dates
- Lot S25133A
- Amount recalled
- 6564 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of foreign substance
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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