# FDA recall D-0221-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2025-01-30.

## Product

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520.  Made in India.  Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152.  NDC: 0904-7216-61

## Reason for recall

Failed Dissolution Specifications.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0221-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-01-30
- **Report date:** 2025-02-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2025

## Citation

> AI Analytics. FDA recall D-0221-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0221-2025. Source: US FDA. Licensed CC0.

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