# FDA recall D-0304-2020

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-11-01.

## Product

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

## Reason for recall

Presence of Foreign substance: identified as a dead ant.

## Distribution

Product was distributed to major distributors/wholesalers throughout the United States.

## Key facts

- **Recall number:** D-0304-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-01
- **Report date:** 2019-11-13
- **Termination date:** 2021-03-04

- **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-0304-2020

## Citation

> AI Analytics. FDA recall D-0304-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0304-2020. Source: US FDA. Licensed CC0.

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