Class III · Lower riskRecall completed
BuPROPion Hydrochloride Extended-Release Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: MR3365, Exp. Feb 17
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 Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
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 byCadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534 foreign manufacturer
| Distributed by / for | Zydus Pharmaceuticals USA inc. Pennington, NJ 08534 |
| NDC | 68382-354-05 |
Show the full FDA record
| Full product label | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05 |
| Recalling firm | Zydus Pharmaceuticals USA Inc |
| Distribution | Nationwide |
| Quantity | 2,472 units |
| Recall initiated | 2016-08-03 |
| Report date | 2016-11-30 |
| Recall completed | 2018-07-12 |
| Recall number | D-0149-2017 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Pennington 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.