FDAFDA · Food and drugs·Recall number D-0593-2025
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.
Published August 27, 2025 · Recall initiated: July 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Cipla USA, Inc.
- Distributor
- U.S. Nationwide.
- Lot
- Lot#: 4IB0519, Exp. 04/30/2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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