FDA Drug recall D-0596-2026
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufa…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufa… by Par Health Usa, citing crystallization; identified as Buprenorphine free base.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0596-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-12 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Health Usa |
| Distribution | US |
Product
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
Reason
Crystallization; identified as Buprenorphine free base
Identifiers
| ndc | 42023-179-05 |
|---|---|
| code_info | Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 |
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-0596-2026%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.