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.
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 15, 2025 |
| Reported | October 29, 2025 |
| Recalling firm | Graviti Pharmaceuticals Private Limited |
| Country / region | India Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide. |
Hazard
Failed Tablet/Capsule Specifications
Affected products
- Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Tela
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