# FDA recall D-0461-2025

> **AvKARE** · Class II · drug recall initiated 2025-05-09.

## Product

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0461-2025
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-09
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0461-2025

## Citation

> AI Analytics. FDA recall D-0461-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0461-2025. Source: US FDA. Licensed CC0.

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