Class II · ModerateActive recall
Duloxetine Delayed-Release Capsules USP 20 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Where it was soldNationwide
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
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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 | Rising Pharm Holdings, Inc., East Brunswick, NJ |
| NDC | 57237-017-60 |
Show the full FDA record
| Full product label | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 |
| Recalling firm | Rising Pharma Holding, Inc. |
| Distribution | Nationwide |
| Quantity | 73,680 bottles |
| Recall initiated | 2024-12-30 |
| Report date | 2025-01-15 |
| Recall completed | — |
| Recall number | D-0189-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | East Brunswick 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.