Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004,
Summary
The FDA issued a Class II for Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: L by Leading Pharma, LLC. Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit..
Details
Source
Drug Recall
External ID
D-0486-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Lot/Code Info: Lots# H03125, H03225, H03325, Exp Date: 2027/08
Quantity Affected: 9384 bottles
Reason for Recall
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-20
Company
Fairfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 82 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Leading Pharma, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Leading Pharma, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Leading Pharma, LLC have FDA actions?
Leading Pharma, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0486-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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