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 numberLots: DT2023001A, DT2023009A, exp date Jan 31, 2025
Where it was soldPA, OH, PR
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 the 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
Made byAurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories foreign manufacturer
| Distributed by / for | Amerisource Health Services LLC |
| NDC | 68001-413-06 |
Show the full FDA record
| Full product label | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 |
| Recalling firm | Amerisource Health Services LLC |
| Distribution | PA, OH, PR |
| Quantity | 37,916 bottles |
| Recall initiated | 2024-11-14 |
| Report date | 2024-12-11 |
| Recall completed | — |
| Recall number | D-0099-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Columbus OH 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.