hydrOXYzine Hydrochloride Oral Solution — Class III drug recall D-0619-2026
Ongoing recall by ANI Pharmaceuticals, Inc., reported 2026-07-01, distributed nationwide. Presence of foreign substance
| Recall number | D-0619-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ANI Pharmaceuticals, Inc., Baudette, MN, United States |
| Recall initiated | 2026-06-02 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 6,564 bottles |
| NDC | 70954-0912, 70954-0912-10 |
| Lot numbers | 25133A |
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 for recall
Presence of foreign substance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0619-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.