FDA Drug recall 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…
- FDA Drug
- Class III
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class III recall of hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN… by Ani Pharmaceuticals, citing presence of foreign substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0619-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-06-02 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ani Pharmaceuticals |
| Distribution | US |
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
Reason
Presence of foreign substance
Identifiers
| ndc | 70954-912-10 |
|---|---|
| code_info | Lot S25133A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.