FDA recall, , Moderate risk
Leading Pharma Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Summary by Recall Canary from the FDA notice
What happened
Leading Pharma, LLC of Fairfield, New Jersey is recalling Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, because of CGMP Deviations and the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. The company began the recall on March 20, 2026, and the FDA added it to its Enforcement Report on April 21, 2026. The product was distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles
- NDC
- 69315-118-01
- Lot code
- H03125
- H03225
- H03325
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Leading Pharma, LLCFairfield, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98628
- Recall number
- D-0486-2026
- Quantity recalled
- 9384 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
