# FDA recall D-0447-2025

> **Alembic Pharmaceuticals Limited** · Class II · drug recall initiated 2025-05-07.

## Product

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0447-2025
- **Recalling firm:** Alembic Pharmaceuticals Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Panchmahal, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2025

## Citation

> AI Analytics. FDA recall D-0447-2025. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0447-2025. Source: US FDA. Licensed CC0.

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