Class II · ModerateActive recall
Duloxetine Delayed-Release Capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) NDC [redacted-phone], Lot # J0786744-061724, Exp. 06/30/2025 b) NDC [redacted-phone], Lot # B3002625-060524, Exp. 10/31/2025
Where it was soldNationwide in the US
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 | RemedyRepack Inc. |
| NDC | 70518-0937-04 |
Show the full FDA record
| Full product label | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Nationwide in the US |
| Quantity | a) 1,564 cards, b) 799 bottles |
| Recall initiated | 2024-12-02 |
| Report date | 2025-01-01 |
| Recall completed | — |
| Recall number | D-0165-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Indiana PA 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.