A large number of generic medications, including drugs for high blood pressure, allergies, and cholesterol, have been recalled across the United States. The recall stems from issues at a Glenmark Pharmaceuticals factory in India, which failed to meet U.S. manufacturing standards, according to the Food and Drug Administration (FDA).
The FDA’s inspection revealed problems such as cross-contamination and inadequate quality control at the Indian facility. As a result, nearly 40 different types of medications produced there are now being recalled. The recall was first announced on March 13, and the FDA classified it as a Class II risk on April 8, meaning the drugs could cause temporary or reversible health effects, but serious harm is unlikely.
Which Drugs Are Affected?
The recall includes 39 medications used to treat various conditions, such as heart disease, seizures, diabetes, and allergies. Some examples are Fenofibrate capsules, used to lower cholesterol, and medications for atrial fibrillation, high blood pressure, and seizures. The full list includes drugs like Gabapentin, Pravastatin, Metformin, Nitroglycerin, and Saxagliptin, among others.
Where Were These Drugs Sold?
These medicines were distributed nationwide, mostly through pharmacies. Some lots of acetaminophen and ibuprofen tablets were sold via Amazon and Walmart, and allergy tablets were distributed by Amazon.
Why Were They Recalled?
The FDA stated that the drugs did not meet current good manufacturing practices, which include proper quality management, testing, and contamination prevention. An inspection in India found that the factory lacked adequate measures to prevent cross-contamination, did not properly review batches, and failed to document testing procedures. Glenmark also sometimes declared test results invalid and retested samples to pass standards, which raises concerns about the reliability of their testing processes.
How Dangerous Is This Recall?
The FDA classified this as a Class II recall, indicating the drugs could cause temporary health issues but are unlikely to cause serious harm. The agency did not report any specific injuries or adverse events linked to these medications.
Additional Context
Glenmark’s Indian plant has faced scrutiny before. Last year, it had to recall medications due to contamination issues, and there were reports of deaths and hospitalizations linked to some of its drugs. The FDA’s investigation found repeated problems with the plant’s manufacturing practices, including inadequate cleaning and testing procedures.
What Should Consumers Do?
People who have any of these recalled medications should stop taking them and consult their healthcare providers for safe alternatives. The FDA did not provide specific guidance, but consulting a doctor is recommended to ensure safety.
This recall highlights ongoing concerns about manufacturing practices at some international drug factories and emphasizes the importance of quality control in medication production.
Related topics:
- The Best 5 Drugs for Low Testosterone
- Tariffs On Chinese Imports Could Raise U.S. Generic Drug Prices, Experts Say
- The Drugs for PCOS: Managing Symptoms & Improving Quality of Life
