Quick Facts at a Glance
- Recall Date
- July 24, 2025
- Hazard Level
- HIGH
- Brands
- Cipla USA Inc., ALBUTEROL SULFATE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cipla USA Inc., ALBUTEROL SULFATE
- Product type
- Inhalation Aerosol
- Model numbers
- Lot#: 4IB0519, Exp. 04/30/2026
- UPC codes
- 69097-142, 69097-142-60
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 24, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Albuterol sulfate inhalation aerosol is a bronchodilator used to treat or prevent bronchospasm in people with reversible obstructive airway disease.
Why This Is Dangerous
The identified issue is a stability failure affecting particle size distribution, which could impact drug delivery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
No injuries reported in the provided data. Consumers should await further instructions from Cipla USA or their healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check Lot 4IB0519
Where to find product info
Product label and packaging display NDC, lot number, and Exp. date.
What timeline to expect
Recall activation started 2025-07-24. Replacement or refund process will be communicated by Cipla USA via mailed letter (no explicit timeline).
If the manufacturer is unresponsive
- Document contact attempts, escalate to Cipla USA corporate or FDA if needed.
- File a consumer complaint with the FDA if no response in a reasonable period.
How to prevent similar issues
- Always verify NDC before use
- Keep medicines in original packaging
- Consult healthcare professionals before stopping a prescribed inhaler
Documentation advice
Keep packaging, lot number, NDC, and recall notice; record dates of contact and responses
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Product Details
Model numbers: Lot 4IB0519. Expiration: 04/30/2026. NDC 69097-142-60. Quantity: 20,352 packs (1x 200 MD). Sold nationwide in the United States. Manufactured by Cipla Ltd, Indore SEZ, Pithampur, India for Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
Reported Incidents
No injuries or incidents are reported in the provided data.
Key Facts
- Distributed nationwide in the U.S.
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Safety Guide
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