Furosemide Tablet
FDA Recall NDC 69315-116
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 69315-116). A significant event, classified as Class II, was initiated on Mar 20, 2026 by Leading Pharma, Llc. The reported reason for this action was: "CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
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
March 2026 Class II Recall: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Mar 20, 2026
Apr 29, 2026
9384 bottles
Recall Profile & Regulatory Data
Event ID
98628
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Leading Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Batch or Lot Expiration Information
Lot# Lots# H03125, H03225, H03325, Exp Date: 2027/08
Affected Packages Involved in this Recall
69315-116-01Product
69315-116-10Product
69315-117-01Product
69315-117-10Product
69315-118-01Product
69315-118-05Product
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.
