July 2025 FDA Recall Albuterol Sulfate by Cipla Usa, Inc.
D-0593-2025 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Cipla Usa, Inc. on July 24, 2025 for the product Albuterol Sulfate. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0593-2025
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.
07-24-2025
08-27-2025
20352 packs (1x 200 MD)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cipla USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 4IB0519, Exp. 04/30/2026
