# FDA recall D-0855-2020

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2020-02-12.

## Product

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06

## Reason for recall

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

## Distribution

Nationwide within the United States.

## Key facts

- **Recall number:** D-0855-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-12
- **Report date:** 2020-02-19
- **Termination date:** 2021-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2020

## Citation

> AI Analytics. FDA recall D-0855-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0855-2020. Source: US FDA. Licensed CC0.

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