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 #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.
Where it was soldNationwide and Puerto Rico
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: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
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 Limited, Ahmedabad, India For BluePoint Laboratories foreign manufacturer
| Distributed by / for | Amerisource Health Services |
| NDC | 68001-264-05 |
Show the full FDA record
| Full product label | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories |
| Recalling firm | Amerisource Health Services |
| Distribution | Nationwide and Puerto Rico |
| Quantity | a) 15,409 bottles b) 5,128 bottles |
| Recall initiated | 2016-10-27 |
| Report date | 2016-11-23 |
| Recall completed | 2017-06-29 |
| Recall number | D-0137-2017 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Columbus OH 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.