Buprenorphine Sublingual Tablets — Class II drug recall D-0869-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-06-14, distributed nationwide. CGMP Deviations
| Recall number | D-0869-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-05-03 |
| Classified | 2023-06-07 |
| Reported by FDA | 2023-06-14 |
| Terminated | 2024-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 12,336 bottles |
| Reason classes | cgmp |
| NDC | 62756-0459, 62756-0459-64, 62756-0459-83, 62756-0460, 62756-0460-64, 62756-0460-83 |
| Lot numbers | 08/24, DND1515A |
Product
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Reason for recall
CGMP Deviations
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-0869-2023. 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.