Drug recall
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI…
FDA recall event 99131 · Class III · ANI Pharmaceuticals, Inc.
Key facts
| Event ID | 99131 |
|---|---|
| Recall numbers | D-0619-2026 |
| Recalling firm | ANI Pharmaceuticals, Inc. |
| Product type | Drugs |
| 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 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of foreign substance |
| Initiation date | Jun 2, 2026 |
| Report date | Jul 1, 2026 |
| City | Baudette |
| State | MN |
| Country | United States |
| FEI number | 2111358 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: