NEW YORK, April 19: Nearly 40 life-saving medications manufactured by Glenmark Pharmaceuticals Inc. have been recalled by the U.S. Food and Drug Administration (FDA) due to concerns over faulty manufacturing practices at the company’s facility in India.

The recall, initially issued on March 13, was formally classified by the FDA as a Class II risk on April 8, indicating that the affected products may cause temporary or medically reversible adverse health effects. While the FDA does not currently anticipate serious illness or death resulting from the recalled medications, the agency emphasized that the manufacturing processes were found to be in violation of Current Good Manufacturing Practice (CGMP) standards, which are critical for ensuring the quality and safety of pharmaceuticals.

The recalled medications span a wide range of treatments, including drugs for epilepsy, diabetes, multiple sclerosis, heart disease, high blood pressure, kidney and bladder issues, atrial fibrillation (irregular heartbeat), stroke, and seizures.

Among the most recognized recalled products are:

Fenofibrate capsules (67 mg) – for lowering blood lipid levels and supporting blood pressure

Solifenacin Succinate tablets (10 mg) – for overactive bladder

Gabapentin tablets (600 mg) – for partial seizures, nerve pain, and restless leg syndrome

A complete list of the recalled drugs includes other vital medications such as Lacosamide, Propafenone, Nitroglycerin, Pravastatin, Rosuvastatin, and Metformin, many of which are commonly prescribed for chronic conditions and typically distributed by pharmacies.

While most of the drugs involved are prescription-only, certain lots of acetaminophen and ibuprofen (NSAID) combination tablets and cetirizine hydrochloride (used for seasonal allergy relief) were distributed through major retailers including Amazon and Walmart. Neither retailer has yet issued a public statement regarding the recall or further distribution actions.

According to Glenmark, its products can be easily identified by a signature “G” imprint on all tablets and capsules. Patients currently using any of the 39 recalled medications are strongly advised to contact their pharmacist or healthcare provider to discuss appropriate next steps.

This recall follows a similar incident in June 2024, when Glenmark Pharmaceuticals voluntarily recalled 135 batches of a blood pressure medication over concerns that the capsule formulation might not properly dissolve upon ingestion. Specifically, 114 batches of 750 mg Potassium Chloride extended-release tablets in bottles of 100 and 500 pills were withdrawn, with all batch numbers and expiration dates listed by the FDA.

Additionally, American Health Packaging recalled 21 batches of the same potassium chloride drug on behalf of BluePoint Laboratories. Improper dissolution of these capsules could potentially lead to hyperkalemia (elevated potassium levels), a serious medical condition that can affect heart rhythm and other bodily functions.

The FDA continues to monitor and enforce compliance with CGMP regulations to protect public health and safety. Patients are encouraged to remain vigilant and check the FDA’s official recall listings for updated information on affected medications.