# FDA recall D-0470-2025

> **Macleods Pharmaceuticals Ltd** · Class III · drug recall initiated 2025-05-29.

## Product

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

## Reason for recall

Presence of a foreign substance: black hair found embedded in tablet.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0470-2025
- **Recalling firm:** Macleods Pharmaceuticals Ltd
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-29
- **Report date:** 2025-06-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2025

## Citation

> AI Analytics. FDA recall D-0470-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0470-2025. Source: US FDA. Licensed CC0.

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