Class III · Lower riskRecall completed
buPROPion HCl Extended-Release Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
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 Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
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 byWockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA foreign manufacturer
| Distributed by / for | Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA |
| NDC | 64679-101-07 |
Show the full FDA record
| Full product label | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | Nationwide |
| Quantity | 840 bottles |
| Recall initiated | 2014-07-14 |
| Report date | 2014-08-13 |
| Recall completed | 2015-01-12 |
| Recall number | D-1513-2014 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany 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.