FDA Recall D-0037-2026
Graviti Pharmaceuticals Private Limited
Class II Ongoing 241 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Failed Tablet/Capsule Specifications
Recall record
- Recall number
D-0037-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Recall initiated
- 2025-09-15
- Classified by FDA Center
- 2025-10-21
- FDA published
- 2025-10-29
- Recalling firm
- Graviti Pharmaceuticals Private Limited
Drug identification
- Brand name(s)
- BUPROPION HYDROCHLORIDE
- Generic name(s)
- BUPROPION HYDROCHLORIDE
- Manufacturer(s)
- Rising Pharma Holdings, Inc.
- NDC(s)
16571-862, 16571-863- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.