# FDA recall D-0423-2019

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-01-09.

## Product

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only   Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland,  Manufactured by: Lupin Limited Mandideep 462 046 India ---  NDC 68180-441-01

## Reason for recall

CGMP Deviations; presence of extraneous material in the  was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

## Distribution

Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-0423-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-09
- **Report date:** 2019-02-06
- **Termination date:** 2020-04-08

- **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-0423-2019

## Citation

> AI Analytics. FDA recall D-0423-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0423-2019. Source: US FDA. Licensed CC0.

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