FDA Drugs recall ·
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations… recall
- Recall number
- D-0593-2025
- Date
- (initiated July 24, 2025)
- Company / brand
- Cipla USA, Inc.
10 Independence Blvd, Warren, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 20352 packs (1x 200 MD)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 4IB0519, Exp. 04/30/2026
Distribution
U.S. Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0593-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.