# FDA recall D-0648-2024

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2024-08-21.

## Product

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

## Reason for recall

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0648-2024
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-08-21
- **Report date:** 2024-09-04
- **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-0648-2024

## Citation

> AI Analytics. FDA recall D-0648-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0648-2024. Source: US FDA. Licensed CC0.

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