Cipla USA recalls albuterol inhalers with potential particle size issues. This may affect stability and safety. Check your NDC 69097-142-60 lot 4IB0519 for affected units.
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.
Take action
Contact the company
📍Recalling firmCipla USA, Inc.10 Independence Blvd · Warren, NJ 07059-2730
✎ GovInfoNow plain-language explainer
Cipla USA is recalling albuterol inhalers that may have unstable particle size, which could lead to safety concerns. This recall affects specific batches produced in India and sold in the U.S. The issue requires immediate attention to prevent potential risks. Read more at govinfonow.com/recall/31957-cipla-albuterol-inhaler-recall-particle-size-risk.
“Cipla Albuterol Inhaler Recall: Particle Size Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31957-cipla-albuterol-inhaler-recall-particle-size-risk. Based on FDA recall #D-0593-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0593-2025%22&limit=1).
The FDA announced on July 24, 2025, that Cipla USA, Inc. is voluntarily recalling Albuterol Sulfate Inhalation Aerosol due to failed stability specifications. The agency issued recall number D-0593-2025 for the Class III product distributed nationwide.
How to tell if you have it
Brand: Cipla
Product: Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g
Manufacturer: Cipla Ltd
NDC: 69097-142-60
Lot#: 4IB0519
Expiration: 04/30/2026
The hazard
The recall addresses out-of-specification results observed in the induction port during particle size distribution analysis at the 12-month time point. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Cipla USA, Inc. has 12 other recalls on record since June 27, 2023. Other recent recalls of similar products include Cipla Phytonadione Injectable Emulsion Recall (Oct. 31, 2025), Lupin Liraglutide 18mg/3mL Injection Recall (April 24, 2026), and American Regent Epinephrine Injection Recall (Aug. 11, 2026).
How to tell if you have this one
Check for the NDC code 69097-142-60 and lot number 4IB0519 on the product label. The product was manufactured in India and sold in the U.S. by Cipla USA, Inc.
Brand
Cipla
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the NDC code 69097-142-60 and lot number 4IB0519 on the inhaler packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0593-2025 (July 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0593-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.