Albuterol Sulfate recall
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India…
Why was Albuterol Sulfate 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 4IB0519, Exp. 04/30/2026
- Product
- Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India…
- Recalling firm
- Cipla USA, Inc.
- Quantity
- 20352 packs (1x 200 MD)
- Distribution
- U.S. Nationwide.
- Recall date
- August 27, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)