# FDA recall D-0031-2026

> **The Harvard Drug Group LLC** · Class II · drug recall initiated 2025-10-10.

## Product

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).

## Reason for recall

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0031-2026
- **Recalling firm:** The Harvard Drug Group LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-10
- **Report date:** 2025-10-29

- **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-0031-2026

## Citation

> AI Analytics. FDA recall D-0031-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0031-2026. Source: US FDA. Licensed CC0.

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