# FDA recall D-0486-2026

> **Leading Pharma, LLC** · Class II · drug recall initiated 2026-03-20.

## Product

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

## Reason for recall

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0486-2026
- **Recalling firm:** Leading Pharma, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-20
- **Report date:** 2026-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0486-2026

## Citation

> AI Analytics. FDA recall D-0486-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0486-2026. Source: US FDA. Licensed CC0.

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