Buprenorphine HCl Injection — Class II drug recall D-1533-2020
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2020-09-02, distributed nationwide. Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
| Recall number | D-1533-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2020-08-14 |
| Classified | 2020-08-21 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 97,890 vials |
| Reason classes | potency, specification failure |
| NDC | 00143-9246, 00143-9246-01, 00143-9246-05 |
| Lot numbers | 2005023.1, 2005024.1, 2005025.1 |
| Expiration dates | 2021-02-28 |
Product
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Reason for recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
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-1533-2020. 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.