# FDA recall D-0496-2024

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2024-04-24.

## Product

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

## Reason for recall

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0496-2024
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-04-24
- **Report date:** 2024-05-22
- **Termination date:** 2025-04-29

- **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-0496-2024

## Citation

> AI Analytics. FDA recall D-0496-2024. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-0496-2024. Source: US FDA. Licensed CC0.

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