# FDA recall D-0629-2020

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-12-10.

## Product

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

## Reason for recall

Failed Dissolution Specifications: High out of specification result observed at stability studies.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0629-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-10
- **Report date:** 2019-12-25
- **Termination date:** 2021-04-29

- **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-0629-2020

## Citation

> AI Analytics. FDA recall D-0629-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0629-2020. Source: US FDA. Licensed CC0.

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