Class III · Lower riskRecall completed
Dicloxacillin Sodium Capsules USP
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
Where it was soldNationwide
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 Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
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 Inc. , Princeton, NJ 08540, Product of Spain |
| NDC | 0781-2258-01 |
Show the full FDA record
| Full product label | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01 |
| Recalling firm | Sandoz, Inc |
| Distribution | Nationwide |
| Quantity | N/A |
| Recall initiated | 2016-05-02 |
| Report date | 2016-06-29 |
| Recall completed | 2017-08-17 |
| Recall number | D-1046-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ 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.