Class II · ModerateRecall completed
DULoxetine DR USP
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
Where it was soldDistributed within US: FL, MS, WI
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: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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 | PD-Rx Pharmaceuticals, Inc. |
| NDC | 43063-877-90 |
Show the full FDA record
| Full product label | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 |
| Recalling firm | PD-Rx Pharmaceuticals, Inc. |
| Distribution | Distributed within US: FL, MS, WI |
| Quantity | 70, 90-count bottles |
| Recall initiated | 2024-12-04 |
| Report date | 2025-01-01 |
| Recall completed | 2025-03-21 |
| Recall number | D-0163-2025 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Oklahoma City OK 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.