hydrOXYzine Hydrochloride Oral Solution recall (ANI Pharmaceuticals, Inc.)
DrugClass IIIOngoing
Summary: ANI Pharmaceuticals, Inc. is recalling 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: Presence of foreign substance.
What is being recalled
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
Why
Presence of foreign substance
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot S25133A
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0619-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | June 2, 2026 |
| Reported | July 1, 2026 |
| Company | ANI Pharmaceuticals, Inc. |
| Company location | Baudette, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6564 bottles |
More recalls from ANI Pharmaceuticals, Inc. · all drug recalls · recalls from June 2026