Recalls / Class III
Class IIID-0593-2025
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.
- Brand name
- Albuterol Sulfate
- Generic name
- Albuterol Sulfate
- Active ingredient
- Albuterol Sulfate
- Route
- Respiratory (inhalation)
- NDC
- 69097-142
- FDA application
- ANDA209959
- Affected lot / code info
- Lot#: 4IB0519, Exp. 04/30/2026
Why it was 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.
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 20352 packs (1x 200 MD)
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2025-07-24
- FDA classified
- 2025-08-20
- Posted by FDA
- 2025-08-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0593-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.