Drug recall D-0593-2025

Class III Ongoing reported Aug 27, 2025

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.

Lots and codes

Lot#: 4IB0519, Exp. 04/30/2026

Recall details

Recalling firm
Cipla USA, Inc., Warren, NJ
Quantity
20352 packs (1x 200 MD)
Distribution
U.S. Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
July 24, 2025

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