FDA Recall D-0293-2026
Graviti Pharmaceuticals Private Limited
Class II Ongoing 124 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Reason for recall
Presence of Foreign Substance
Recall record
- Recall number
D-0293-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2026-01-10
- Classified by FDA Center
- 2026-01-21
- FDA published
- 2026-01-28
- Recalling firm
- Graviti Pharmaceuticals Private Limited
Drug identification
- Brand name(s)
- FUROSEMIDE
- Generic name(s)
- FUROSEMIDE
- Manufacturer(s)
- Rising Pharma Holdings, Inc.
- NDC(s)
64980-562, 64980-563, 64980-564- 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.