Furosemide Tablets Recall by Leading Pharma
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,046 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.