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.
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.
The inhaler may have particle size distribution issues that could affect its stability over time. This might lead to inconsistent medication delivery or safety concerns if the product degrades.
People who own or use the recalled albuterol inhalers with NDC 69097-142-60 and lot number 4IB0519 are affected. Those with asthma or respiratory conditions are at higher risk due to potential instability.
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.
Look for the NDC code 69097-142-60 and lot number 4IB0519 on the inhaler packaging.
The recall indicates potential stability issues, but the official notice does not specify if it is safe to use. Affected units should be checked for the specific lot number.
The recall does not provide a remedy, so the official notice does not specify actions to take. Check the product label for the NDC code and lot number.
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.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0593-2025 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0593-2025 from Cipla. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.