Class II · ModerateActive recall
Duloxetine Delayed-Release Capsules USP 30 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, 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 | 57237-018-30 |
Show the full FDA record
| Full product label | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ |
| Recalling firm | Rising Pharma Holding, Inc. |
| Distribution | Nationwide |
| Quantity | 42,527 bottles |
| Recall initiated | 2024-12-30 |
| Report date | 2025-01-15 |
| Recall completed | — |
| Recall number | D-0188-2025 |
| 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.