# FDA recall D-0221-2024

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2023-12-20.

## Product

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.

## Reason for recall

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0221-2024
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-12-20
- **Report date:** 2024-01-17
- **Termination date:** 2025-04-04

- **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-0221-2024

## Citation

> AI Analytics. FDA recall D-0221-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0221-2024. Source: US FDA. Licensed CC0.

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