Class II · ModerateActive recall
Bupropion Hydrochloride Extended-Release Tablets USP (XL)
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # BPB124341A, Exp date: 10/2026
Where it was soldProduct was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
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 Tablet/Capsule Specifications
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 | Graviti Pharmaceuticals Private Limited |
| NDC | 16571-863-03 |
Show the full FDA record
| Full product label | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. |
| Recalling firm | Graviti Pharmaceuticals Private Limited |
| Distribution | Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide. |
| Quantity | 46,512/30 count bottles |
| Recall initiated | 2025-09-15 |
| Report date | 2025-10-29 |
| Recall completed | — |
| Recall number | D-0037-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Hyderabad India |
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.