FDA Drug recall D-0527-2026
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 420…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 420… by Endo Usa, citing crystallization; identified as Buprenorphine free base.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0527-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-13 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Endo Usa |
| Distribution | US |
Product
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Reason
Crystallization; identified as Buprenorphine free base
Identifiers
| ndc | 42023-179-05 |
|---|---|
| code_info | Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027 |
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-0527-2026%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.