Buprenorphine Hydrochloride — Class II drug recall D-0527-2026
Ongoing recall by ENDO USA, Inc., reported 2026-05-20, distributed nationwide. Crystallization; identified as Buprenorphine free base
| Recall number | D-0527-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ENDO USA, Inc., Rochester, MI, United States |
| Recall initiated | 2026-03-13 |
| Classified | 2026-05-11 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 34,293 vials |
| NDC | 42023-0179, 42023-0179-05 |
| Lot numbers | 84132, 87693 |
| Expiration dates | 2027-02-28, 2027-03-31 |
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 for recall
Crystallization; identified as Buprenorphine free base
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-0527-2026. 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.