Recalls / Class II
Class IID-0293-2026
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.
- Brand name
- Furosemide
- Generic name
- Furosemide
- Active ingredient
- Furosemide
- Route
- Oral
- NDCs
- 64980-562, 64980-563, 64980-564
- FDA application
- ANDA216629
- Affected lot / code info
- Lot# FUB125042G; Exp. 05/13/2027
Why it was recalled
Presence of Foreign Substance
Recalling firm
- Firm
- Graviti Pharmaceuticals Private Limited
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- E & 621 Patancheru Mandal, Isnapur Village Rd; Survey No 621, Hyderabad, N/A, India
Distribution
- Quantity
- 4212 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2026-01-10
- FDA classified
- 2026-01-21
- Posted by FDA
- 2026-01-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0293-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.