Last Updated on September 7, 2025 by The Health Master
Drug recall
In an unexpected turn of events that has caught the eye of regulators, Glenmark Pharmaceuticals has issued a voluntary drug recall of two of their most dispensed drugs in the United States: Carvedilol and Theophylline.
This is an important event to pay attention to as it reminds us why drug manufacturing must be held to a golden standard.
Drug recall: Which are the recalled drugs?
First, let’s get acquainted with who they are—and what do they do in the drug world?
Carvedilol:
This is a strong beta-blocker that treats hypertension.
It blocks receptors in the body, allowing blood vessels to relax and expand, reducing resistance to blood flow.
It’s an important part of millions of people’s health regimens, helping to maintain normal blood pressure.
Theophylline:
This is used to treat chronic obstructive pulmonary disease (COPD) and asthma.
It works to relax muscles around the air canals of the lungs to allow easier breathing.
By expanding the air canals, it helps improve quality of life for those experiencing respiratory disease.
Reason for the drug recall:
The reasons for the drug recall differ but stem from complications during manufacturing.
Carvedilol:
The Impurity Concern: The drug recall of Carvedilol tablets is related to an impurity known as N-Nitroso Carvedilol Impurity-1 (NNCI) that was found above the FDA’s acceptable limit of 4.0 ppm.
This is serious because sometimes, a little bit here or there can lead to serious impacts later.
The recalled lots for this favorite of many were on August 6 and 7, 2025, from Glenmark’s manufacturing sites of Goa and Pithampur in India, totaling more than 88,000 bottles.
Theophylline:
The Dissolution Concern: The reason for the drug recall of Theophylline tablet was that the lot failed to meet “Dissolution Specifications,” meaning it was not dissolving during testing that simulated human-like conditions.
This means that people would experience sub-therapeutic levels of the medication.
This voluntary drug recall occurred from stability testing at the long-term shelf life interval on August 8, 2025, involving more than 22,000 tested bottles.
Q: What should I do if I currently have these pills in my home?
A: If you are on Carvedilol or Theophylline, it’s best to check with your brand and lot numbers to be safe, but contact your pharmacist or primary caregiver immediately to ascertain if your medications fall within the recalls. Do not stop taking any medications without first consulting your medical professional.
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.
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