Furosemide Tablet
FDA Recall NDC 64980-562

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Furosemide (NDC 64980-562). A significant event, classified as Class II, was initiated on Jan 10, 2026 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Presence of Foreign Substance"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0293-2026ONGOING

January 2026 Class II Recall: Presence of Foreign Substance

Recall Number
D-0293-2026
Class II Ongoing
Reason for Recall
Presence of Foreign Substance
Initiated
Jan 10, 2026
Reported
Jan 28, 2026
Quantity
4212 bottles

Recall Profile & Regulatory Data

Event ID
98289
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Graviti Pharmaceuticals Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# FUB125042G; Exp. 05/13/2027
Affected Packages Involved in this Recall
64980-562-01Product
64980-562-10Product
64980-563-01Product
64980-563-10Product
64980-564-01Product
64980-564-50Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.