Last Updated on September 14, 2025 by The Health Master
Drug recall
In a safety-related drug recall, Cipla, the American parent of the pharmaceutical company Cipla is recalling one lot of the asthma medication Albuterol Sulfate.
According to news outlets, this is not a major national safety issue; however, the company chose to recall its product and not distribute it due to an out-of-specification finding for a stability test at 12 months post-release. Therefore, this is a Class III drug recall.
Why this drug recall by Cipla?
On August 20, 2025, Cipla issued a drug recall for 20,352 packs of Albuterol Sulfate Inhalation Aerosol.
After a routine annual review for the drug’s standard shelf life, it found that at 12 months, the particle size was larger than acceptable in the induction port of the drug it was related to.
As a result of this finding, the company decided to recall the inhaler. However, since this is NOT a serious health concern, it is a Class III drug recall.
What Are Drug Recall Classes?
The classes of recalls set forth by the USFDA are important to understand so that the public can recognize how severe a drug recall is relative to other products.
- Class I: The most severe class of recall; recalls items that will cause adverse health effects and/or death.
- Class II: Recalls items that may cause temporary or reversible health effects.
- Class III: Recalls items that have small flaws in manufacturing and are unlikely to cause adverse health effects.
Thus, Cipla’s Albuterol Sulfate recall is a Class III drug recall, which means this is NOT a major health concern for patients.
What is Albuterol Sulfate For?
For many people, Albuterol Sulfate is critical for their respiratory health. Brand name ProAir is a bronchodilator that relaxes the muscles in the airways.
As an inhaler that sprays medication directly into the lungs, patients can feel relief almost immediately during an asthma episode.
What Should Patients Do?
If you have this product in your possession, do not panic. Class III recalls mean that this product is unlikely to cause adverse health consequences.
However, as a precautionary measure, check your inhaler lot number and expiration date to see if you are part of the drug recall.
- Determine the product name and packaging from your Albuterol inhaler to see if you are part of the drug recall.
- Contact your doctor or pharmacist with additional questions.
- Do NOT discontinue prescribed medications without consulting your healthcare professional.
Q: Is Class III drug recall a major health concern?
A: No. It is a Class III drug recall concern, which is a minor manufacturing imperfection and NOT likely to cause any health issues.
Q: What if my inhaler is part of the recalled lot?
A: Speak with your pharmacy for a potential exchange. Do NOT discontinue medication without speaking to your doctor or getting a replacement.
Q: Is Cipla recalling additional lots?
A: No. Cipla is only recalling this specific lot of Albuterol Sulfate.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
Drug recall: Glenmark recalls High BP, COPD drug
Drug recall: Alembic recalls 9,492 bottles of Doxepin Capsules
Drug recall: Sun Pharma recalls 11,328 bottles of BP drug
NSQ drug recall time reduced – 30 days to 3 days
PCI: Final Warning to Institutions on Biometric Attendance
DCA Telangana busts illegal drug trade
Alert on theft: Multiple drugs of Novo Nordisk Stolen
PCI releases new draft Syllabus for B. Pharm
Drugs Rules amended to include qualitative data of excipients
Drug recall: Glenmark recalls High BP, COPD drug
4 dead in Gas Leak at a Pharma Plant: Maharashtra
Action Against Misleading Pharma Ads, Sale Of NSQ Drugs
