# FDA recall D-0485-2026

> **The Harvard Drug Group LLC** · Class II · drug recall initiated 2026-03-24.

## Product

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC  0904-6734-61

## Reason for recall

Failed Dissolution Specifications

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0485-2026
- **Recalling firm:** The Harvard Drug Group LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-24
- **Report date:** 2026-04-22

- **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-0485-2026

## Citation

> AI Analytics. FDA recall D-0485-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0485-2026. Source: US FDA. Licensed CC0.

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