Furosemide Tablets recall
FDA recall D-0486-2026 · initiated Mar 20, 2026
Leading Pharma, LLC recalled Furosemide Tablets in Mar 2026 — an FDA Class II recall (D-0486-2026) because CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9384 bottles
Details
- Product
- Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
- Recalling company
- Leading
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 20, 2026
- FDA report date
- Apr 29, 2026
Frequently asked
- Was Furosemide Tablets recalled?
- Leading Pharma, LLC recalled Furosemide Tablets in Mar 2026 — an FDA Class II recall (D-0486-2026) because CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Furosemide Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0486-2026 was: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- Is a recalled Furosemide Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Furosemide Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lots# H03125, H03225, H03325, Exp Date: 2027/08. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0486-2026.