# FDA recall D-0541-2025

> **Cipla USA, Inc.** · Class II · drug recall initiated 2025-06-30.

## Product

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

## Reason for recall

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0541-2025
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-30
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2025

## Citation

> AI Analytics. FDA recall D-0541-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0541-2025. Source: US FDA. Licensed CC0.

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