Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg — Class II drug recall D-0024-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-11-09, distributed nationwide. Presence of Foreign Substance
| Recall number | D-0024-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-10-18 |
| Classified | 2022-10-31 |
| Reported by FDA | 2022-11-09 |
| Terminated | 2023-09-07 |
| Distributed | Nationwide (US) |
| NDC | 62756-0969, 62756-0969-64, 62756-0969-83, 62756-0970, 62756-0970-64, 62756-0970-83 |
| Lot numbers | DNC1129A, DNC1740A |
| Expiration dates | 2023-06, 2023-09 |
Product
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
Reason for recall
Presence of Foreign Substance
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-0024-2023. 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.