# FDA recall D-1262-2020

> **The Harvard Drug Group** · Class III · drug recall initiated 2020-04-24.

## Product

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

## Reason for recall

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

## Distribution

AL, FL, IA, NY, OH, TX

## Key facts

- **Recall number:** D-1262-2020
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-04-24
- **Report date:** 2020-05-20
- **Termination date:** 2022-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1262-2020

## Citation

> AI Analytics. FDA recall D-1262-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1262-2020. Source: US FDA. Licensed CC0.

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