On July 11, 2025, the U.S. Food and Drug Administration (FDA) issued a new warning letter to Glenmark Pharmaceuticals Limited. This letter outlines continuing significant violations of current good manufacturing practices (CGMP), particularly related to the production of extended-release potassium chloride capsules.
Key Issues Identified by the FDA
- Inadequate Investigations: Glenmark failed to properly investigate and address test results that showed certain lots of potassium chloride capsules did not meet dissolution specifications during stability testing.
- Test Failures: The capsules failed to dissolve as intended over time, raising concerns that patients may not receive the correct amount of medication throughout the dosing period.
- Repeat Deficiencies: The FDA noted that Glenmark has received similar warnings in the past, including a 2022 warning letter, and has not fully corrected underlying systemic issues.
Why This Matters
Potassium chloride is a critical medication used to treat or prevent low blood potassium levels. Improper dissolution of extended-release capsules can result in patients receiving either too little or too much of the active ingredient, potentially leading to serious health consequences such as hyperkalemia—a condition that can be life-threatening if not properly managed.
This warning follows a Class I recall Glenmark issued in June 2024 for the same potassium chloride product due to similar concerns about dissolution failures.
Until the company resolves these issues, the FDA may withhold approval of new applications or supplements from the facility, and further enforcement action may follow if problems persist.
Relevance to Butler v. Glenmark Pharmaceuticals Inc., USA
The concerns raised in the FDA’s latest warning letter are directly related to the claims brought in the class action Butler v. Glenmark Pharmaceuticals Inc., USA. In this case, our firm represents individuals who purchased potassium chloride extended-release capsules manufactured by Glenmark, alleging that the products were defective and failed to perform as promised. This new warning letter reinforces allegations that Glenmark has consistently failed to comply with basic manufacturing standards, placing patient safety at risk.
We will continue to monitor this situation closely and provide updates as developments arise in both the regulatory proceedings and the ongoing litigation. If you or a loved one has taken potassium chloride manufactured by Glenmark Pharmaceuticals that you believe may have been affected, please contact us today.
