# FDA recall D-0045-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class III · drug recall initiated 2024-11-05.

## Product

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

## Reason for recall

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

## Distribution

Nationwide in the US.

## Key facts

- **Recall number:** D-0045-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-11-05
- **Report date:** 2024-11-20
- **Termination date:** 2025-09-16

- **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-0045-2025

## Citation

> AI Analytics. FDA recall D-0045-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0045-2025. Source: US FDA. Licensed CC0.

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