# FDA recall D-0507-2025

> **The Harvard Drug Group LLC** · Class II · drug recall initiated 2025-06-19.

## Product

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

## Reason for recall

Defective container; blister packaging inadequately sealed.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0507-2025
- **Recalling firm:** The Harvard Drug Group LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-19
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0507-2025

## Citation

> AI Analytics. FDA recall D-0507-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0507-2025. Source: US FDA. Licensed CC0.

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