FDA DrugsClass II
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising ...
Published: January 28, 2026Recall ID: D-0293-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Foreign Substance
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Hyderabad |
| Openfda › Nui › 1 | N0000175366 |
| Openfda › Nui › 2 | N0000175590 |
| Openfda › Upc | 0364980564014 |
| Openfda › Unii | 7LXU5N7ZO5 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197732 |
| Openfda › Rxcui › 2 | 310429 |
| Openfda › Rxcui › 3 | 313988 |
| Openfda › Spl id | 458b3c62-666c-43f2-8feb-ee8e6cbe8931 |
| Openfda › Brand name | FUROSEMIDE |
| Openfda › Spl set id | 6101b9b4-f3ef-438e-a857-b4ea55ffc679 |
| Openfda › Package ndc › 1 | 64980-562-01 |
| Openfda › Package ndc › 2 | 64980-562-10 |
| Openfda › Package ndc › 3 | 64980-563-01 |
| Openfda › Package ndc › 4 | 64980-563-10 |
| Openfda › Package ndc › 5 | 64980-564-01 |
| Openfda › Package ndc › 6 | 64980-564-50 |
| Openfda › Product ndc › 1 | 64980-562 |
| Openfda › Product ndc › 2 | 64980-563 |
| Openfda › Product ndc › 3 | 64980-564 |
| Openfda › Generic name | FUROSEMIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Increased Diuresis at Loop of Henle [PE] |
| Openfda › Substance name | FUROSEMIDE |
| Openfda › Pharm class epc | Loop Diuretic [EPC] |
| Openfda › Manufacturer name | Rising Pharma Holdings, Inc. |
| Openfda › Application number | ANDA216629 |
| Openfda › Is original packager | true |
| Event id | 98289 |
| Address 1 | E & 621 Patancheru Mandal |
| Address 2 | Isnapur Village Rd; Survey No 621 |
| Code info | Lot# FUB125042G; Exp. 05/13/2027 |
| Postal code | N/A |
| Report date | 20260128 |
| Product type | Drugs |
| Product quantity | 4212 bottles |
| Reason for recall | Presence of Foreign Substance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260110 |
| Initial firm notification | Letter |
| Center classification date | 20260121 |
Overview
- Recalling FirmGraviti Pharmaceuticals Private Limited
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide