# FDA recall D-0182-2025

> **FDC Limited** · Class II · drug recall initiated 2024-12-16.

## Product

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

## Reason for recall

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0182-2025
- **Recalling firm:** FDC Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-16
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aurangabad, Maharashtra State, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2025

## Citation

> AI Analytics. FDA recall D-0182-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0182-2025. Source: US FDA. Licensed CC0.

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