# FDA recall D-0403-2025

> **FDC Limited** · Class II · drug recall initiated 2025-04-18.

## Product

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

## 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

U.S. Nationwide

## Key facts

- **Recall number:** D-0403-2025
- **Recalling firm:** FDC Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-18
- **Report date:** 2025-05-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0403-2025

## Citation

> AI Analytics. FDA recall D-0403-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0403-2025. Source: US FDA. Licensed CC0.

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