Furosemide Tablets Recall by Leading Pharma

Source: FDA · United States

Leading Pharma, LLC is voluntarily recalling 9,384 bottles of Furosemide Tablets, USP, 80 mg due to CGMP deviations and the presence of N-nitroso-Furosemide above recommended limits.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Leading Pharma, LLC is recalling Furosemide Tablets due to CGMP deviations and the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. This is a voluntary recall initiated by the firm.

Which Products Are Affected

The affected products are Furosemide Tablets, USP, 80 mg, in 100-tablet bottles. The National Drug Code (NDC) is 69315-118-01. The recall involves lots H03125, H03225, and H03325, with an expiration date of 2027/08. A total of 9,384 bottles are affected, distributed nationwide in the United States.

What You Should Do

Consumers who have the affected products should contact Leading Pharma, LLC for instructions, as the initial notification was made via letter. The firm's address is 3 Oak Rd, Fairfield, NJ 07004-2903.

Why This Matters

This recall involves a prescription drug used for treating conditions like edema, potentially affecting patients who rely on it, and highlights ongoing efforts to ensure pharmaceutical safety standards.

Source

FDA Recall Number: D-0486-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Leading Pharma, LLC is voluntarily recalling 9,384 bottles of Furosemide Tablets, USP, 80 mg due to CGMP deviations and the presence of N-nitroso-Furosemide above recommended limits.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.