CLASS II ONGOING Drug recall · Reported 28 Jan 2026 · FDA Enforcement Report
Furosemide Tablets, USP 40 mg recalled by Graviti Pharmaceuticals
Graviti Pharmaceuticals Private is recalling Furosemide Tablets, USP 40 mg, distributed nationwide in the US. The recall was initiated on 10 Jan 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0293-2026
- FDA event ID
- 98289
- Recalling firm
- Graviti Pharmaceuticals Private, Hyderabad
- Brand
- Furosemide
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jan 2026
- FDA classified
- 21 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 10 Jan 2026 | Recall initiated by company | |
| 21 Jan 2026 | Classified by FDA | +11 days |
| 28 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance
Which lots are affected?
Lot# FUB125042G; Exp. 05/13/2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Graviti Pharmaceuticals Private
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg* recalled | Graviti Pharmaceuticals Private | Other | Nationwide |
Other Furosemide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide | Leading Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Furosemide Tablets USP, 20 mg recalled by Roxane LaboratoriesFurosemide | Roxane Laboratories | Other | Nationwide |
| Drug | CLASS II | Furosemide 20 mg/mL svn Sol, Rx recalled by Western Drug | Western Drug | Sterility | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |