- Product
- 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 company
- Graviti Pharmaceuticals Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Initiated
- Sep 15, 2025
- FDA report date
- Oct 29, 2025