The pills may fail to dissolve properly, and batches made from November 2024 to September 2025 all had this defect. Basically, they have potential to not work when in the body.
“This medication is the No. 1 selling drug in the U.S., with over 115 million prescriptions going to more than 29 million Americans,” reports The Conversation, a content partner of the Associated Press.
Hundreds of thousands of patients are affected by this recall.
The Conversation says “it’s only the latest in a series of concerning manufacturing issues that have come to light since 2019," citing a report from ProPublica.
➡️See the Atorvastatin recall and list of products here.
The new value listed by the FDA says this is the info to look for:
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Anyone who thinks they are affected should first contact their doctor before they stop taking it.
More from The Conversation
Pattern of lapses for overseas manufacturers
While the defective atorvastatin is distributed by a U.S. company, it is actually manufactured by Alkem Laboratories in India.
In fact, many aspects of pharmaceutical drug manufacturing are now occurring overseas, primarily in China and India. This has limited the FDA’s ability to provide the oversight required for drugs sold in the U.S.
In the 1990s and early 2000s, the FDA performed routine surveillance inspections of U.S. manufacturing plants every three years, but seldom conducted them overseas. In the wake of several high-profile manufacturing quality lapses, including at the Indian generic drug giant Ranbaxy Laboratories, Congress established a funding mechanism and the FDA established a universal standard for inspecting both U.S. and overseas manufacturers every five years.
However, the U.S. fell behind with international inspections after COVID-19 shut down international travel, and it has yet to catch up. Additionally, overseas manufacturers generally get warning of an upcoming inspection, making the process potentially less rigorous than in the U.S.
A lack of inspections for eye drop manufacturers, especially in India, led to massive recalls in 2023 after a wave of rare eye infections caused some people to lose their eyesight. The problem was traced to widespread unsanitary manufacturing conditions and improper testing for sterility at overseas facilities.
In 2024, eight deaths and multiple hospitalizations led an Indian manufacturer, Glenmark Pharmaceuticals, to recall 47 million potassium chloride extended-release capsules that did not dissolve properly. In February 2025, inspectors found that the company had falsified quality results.
The FDA recently started laboratory spot testing of prescription and over-the-counter drugs arriving in the U.S. to compensate for these limitations. Outside laboratories such as Valisure also do independent testing. Independent testing has caught several dangerous products, but due to limited resources, only a few products can be tested each year.
In 2023, Alkem Laboratories, which manufactured the currently recalled atorvastatin, had to recall 58,000 bottles of the blood pressure drug metoprolol XL because the pills also did not properly dissolve. Spot testing also led to widespread recalls after FDA and Valisure laboratories found cancer-causing chemicals called nitrosamines in some blood pressure, diabetes and indigestion drugs tested between 2019 and 2020, as well as benzene in numerous sunscreen and antibacterial gel products tested between 2020 and early 2025.
Raising consumer vigilance
With these growing gaps in oversight, it’s reasonable to be mindful of changes in how a particular medication affects you. If your prescription drug suddenly stops working, it might be because that particular batch of the medication was not manufactured properly. Alerting the FDA about sudden loss of drug effectiveness could help the agency more quickly identify manufacturing issues.
In 2024, the FDA started sharing the inspection burden with other regulatory agencies like the European Medicines Agency for the European Union. Such coordinated efforts could lead to less duplication and a bump in inspections of overseas manufacturers.
In the meantime, however, consumers are largely at the mercy of spotty inspections and testing, and rarely hear about problems unless poorly manufactured drugs cause widespread adverse events.
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