# FDA recall D-0050-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class II · drug recall initiated 2024-11-07.

## Product

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

## Reason for recall

Failed Impurity/Degradation Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0050-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-11-07
- **Report date:** 2024-11-27
- **Termination date:** 2026-03-05

- **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-0050-2025

## Citation

> AI Analytics. FDA recall D-0050-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0050-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*