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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: 4IB0519, Exp. 04/30/2026
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0593-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jul 24, 2025
- FDA report date
- Aug 27, 2025
- Quantity
- 20352 packs (1x 200 MD)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0593-2025, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97304
- Address
- 10 Independence Blvd
- Code information
- Lot#: 4IB0519, Exp. 04/30/2026
- Postal code
- 07059-2730
- Report date
- Aug 27, 2025
- Product type
- Drugs
- Recall number
- D-0593-2025
- Classification
- Class III
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 20352 packs (1x 200 MD)
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Jul 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2025