FDA Drug recall D-0024-2023
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing presence of Foreign Substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0024-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-18 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Presence of Foreign Substance
Identifiers
| ndc | 62756-969-83 |
|---|---|
| ndc | 62756-969-64 |
| ndc | 62756-970-83 |
| ndc | 62756-970-64 |
| code_info | Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0024-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.