# FDA recall D-0509-2025

> **Macleods Pharmaceuticals Ltd** · Class III · drug recall initiated 2025-06-11.

## Product

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

## Reason for recall

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0509-2025
- **Recalling firm:** Macleods Pharmaceuticals Ltd
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-11
- **Report date:** 2025-07-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2025

## Citation

> AI Analytics. FDA recall D-0509-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0509-2025. Source: US FDA. Licensed CC0.

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