Class III · Lower riskRecall completed
Bupropion
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numbera) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
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; 6 month 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
| Brand name | BUPROPION |
| Generic name | BUPROPION |
| Active ingredient(s) | BUPROPION HYDROCHLORIDE |
| Distributed by / for | Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 |
| NDC | 68382-354-06 |
Show the full FDA record
| Full product label | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 |
| Recalling firm | Zydus Pharmaceuticals USA Inc |
| Distribution | Nationwide |
| Quantity | 16,356 bottles |
| Recall initiated | 2016-11-02 |
| Report date | 2016-12-28 |
| Recall completed | 2020-07-23 |
| Recall number | D-0207-2017 |
| 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.