Fentanyl Buccal Tablets CII — Class III drug recall D-0768-2023
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2023-05-31, distributed nationwide. Labeling: Incorrect or Missing Package Insert
| Recall number | D-0768-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2023-04-27 |
| Classified | 2023-05-24 |
| Reported by FDA | 2023-05-31 |
| Terminated | 2024-02-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,272 |
| Reason classes | labeling |
| NDC | 51862-0636-28 |
| Lot numbers | 100020351, 100020522, 100026700 |
| Expiration dates | 2024-09, 2024-11 |
Product
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Reason for recall
Labeling: Incorrect or Missing Package Insert
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-0768-2023. 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.