Class III · Lower riskRecall completed
Fluoxetine Capsules USP
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot ET5122, Exp. 10/17
Where it was soldAZ
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
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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 | Sandoz Incorporated |
| NDC | 0781-2822-01 |
Show the full FDA record
| Full product label | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 |
| Recalling firm | Sandoz Incorporated |
| Distribution | AZ |
| Quantity | 1,008 bottles |
| Recall initiated | 2014-12-05 |
| Report date | 2014-12-17 |
| Recall completed | 2015-06-24 |
| Recall number | D-0291-2015 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Broomfield CO 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.