# FDA recall D-0519-2025

> **ACCORD HEALTHCARE, INC.** · Class II · drug recall initiated 2025-06-20.

## Product

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17

## Reason for recall

Subpotent Drug:  Assay below the approved specification

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0519-2025
- **Recalling firm:** ACCORD HEALTHCARE, INC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-20
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raleigh, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2025

## Citation

> AI Analytics. FDA recall D-0519-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0519-2025. Source: US FDA. Licensed CC0.

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