Buprenorphine HCl — Class II drug recall D-0087-2024
Terminated recall by PAR Sterile Products LLC, reported 2023-11-15, distributed nationwide. Crystallization; identified as Buprenorphine free base
| Recall number | D-0087-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PAR Sterile Products LLC, Rochester, MI, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2023-11-04 |
| Reported by FDA | 2023-11-15 |
| Terminated | 2024-09-29 |
| Distributed | Nationwide (US) |
| NDC | 42023-0179, 42023-0179-05 |
| Lot numbers | 26921, 343716, 350565, 36227 |
| Expiration dates | 2021-11, 2022-07, 2023-02 |
Product
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, 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-0087-2024. 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.