Class III · Lower riskRecall completed
Fentanyl Buccal Tablets CII
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024
Where it was soldUS Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Incorrect or Missing Package Insert
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Mayne Pharma, Greenville, NC 27834 |
| NDC | 51862-636-28 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Distribution | US Nationwide |
| Quantity | 1272 |
| Recall initiated | 2023-04-27 |
| Report date | 2023-05-31 |
| Recall completed | 2024-02-29 |
| Recall number | D-0768-2023 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.