FDA DrugsClass III
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on...
Published: July 1, 2026Recall ID: D-0619-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of foreign substance
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Baudette |
| State | MN |
| Openfda › Upc | 0370954912101 |
| Openfda › Unii | 76755771U3 |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 995241 |
| Openfda › Spl id | 43889411-a303-41a1-b03b-1ee46f452c54 |
| Openfda › Brand name | HYDROXYZINE HYDROCHLORIDE |
| Openfda › Spl set id | 43889411-a303-41a1-b03b-1ee46f452c54 |
| Openfda › Package ndc | 70954-912-10 |
| Openfda › Product ndc | 70954-912 |
| Openfda › Generic name | HYDROXYZINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | HYDROXYZINE DIHYDROCHLORIDE |
| Openfda › Manufacturer name | ANI Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA219648 |
| Openfda › Is original packager | true |
| Event id | 99131 |
| Address 1 | 210 W Main St |
| Address 2 | N/A |
| Code info | Lot S25133A |
| Postal code | 56623-2467 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 6564 bottles |
| Reason for recall | Presence of foreign substance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260602 |
| Initial firm notification | Letter |
| Center classification date | 20260624 |
Overview
- Recalling FirmANI Pharmaceuticals, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the USA