FDA-Drug2025-08-27Class III
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.
Cipla USA, Inc.
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.
Sold states
U.S. Nationwide.
Affected count
20352 packs (1x 200 MD)
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0593-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief