# FDA recall D-0402-2026

> **Chiesi USA, Inc.** · Class II · drug recall initiated 2026-03-17.

## Product

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0402-2026
- **Recalling firm:** Chiesi USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-17
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cary, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2026

## Citation

> AI Analytics. FDA recall D-0402-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/D-0402-2026. Source: US FDA. Licensed CC0.

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