# FDA recall D-0593-2025

> **Cipla USA, Inc.** · Class III · drug recall initiated 2025-07-24.

## Product

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.

## Reason for recall

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0593-2025
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-24
- **Report date:** 2025-08-27

- **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-0593-2025

## Citation

> AI Analytics. FDA recall D-0593-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0593-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*