Class III · Lower riskRecall completed
Duloxetine Delayed-Release Capsules
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.
Where it was soldNationwide, Alaska, Hawaii, and Puerto Rico.
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
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
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 byApotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326
| Distributed by / for | Apotex Corp. Weston Florida 33326 |
| NDC | 60505-2997-3 |
Show the full FDA record
| Full product label | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737; |
| Recalling firm | Apotex Scientific, Inc |
| Distribution | Nationwide, Alaska, Hawaii, and Puerto Rico. |
| Quantity | 605,989 (30 ct) bottles |
| Recall initiated | 2016-01-26 |
| Report date | 2016-07-20 |
| Recall completed | 2022-06-15 |
| Recall number | D-1436-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Arlington TX 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.