Drug recall
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For…
FDA recall event 99237 · Class II · Par Health USA, LLC
Key facts
| Event ID | 99237 |
|---|---|
| Recall numbers | D-0596-2026 |
| Recalling firm | Par Health USA, LLC |
| Product type | Drugs |
| Products | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Crystallization; identified as Buprenorphine free base |
| Initiation date | Jun 12, 2026 |
| Report date | Jun 24, 2026 |
| City | Rochester |
| State | MI |
| Country | United States |
| FEI number | 1818977 |
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: