{"id":119880,"date":"2025-11-07T04:32:10","date_gmt":"2025-11-07T04:32:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/119880\/"},"modified":"2025-11-07T04:32:10","modified_gmt":"2025-11-07T04:32:10","slug":"atorvastatin-recall-may-affect-hundreds-of-thousands-of-patients-and-reflects-fdas-troubles-inspecting-medicines-made-overseas","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/119880\/","title":{"rendered":"Atorvastatin Recall May Affect Hundreds of Thousands of Patients – and Reflects FDA’s Troubles Inspecting Medicines Made Overseas"},"content":{"rendered":"

If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of\u00a0news coverage<\/a>\u00a0since\u00a0late October 2025<\/a>\u00a0about an extensive recall of thousands of bottles of atorvastatin, the generic version of Lipitor.<\/p>\n

Both generic atorvastatin and brand-name Lipitor contain the same active ingredient, atorvastatin calcium, and are considered bioequivalent by the Food and Drug Administration. This medication is the\u00a0No. 1-selling drug<\/a>\u00a0in the U.S., with over 115 million prescriptions going to more than 29 million Americans.<\/p>\n

I am a\u00a0clinical pharmacologist and pharmacist<\/a>\u00a0who has assessed the manufacturing quality of\u00a0prescription<\/a>,\u00a0over-the-counter<\/a>\u00a0and\u00a0illicit drugs<\/a>, as well as\u00a0dietary supplements<\/a>.<\/p>\n

This atorvastatin recall is large, potentially affecting hundreds of thousands of patients. But it\u2019s only the latest in a\u00a0series of concerning manufacturing issues<\/a>\u00a0that have come to light since 2019.<\/p>\n

What pills are being recalled, and why?<\/p>\n

Ascend Laboratories, based in New Jersey, originally issued the recall for\u00a0about 142,000 bottles<\/a>\u00a0of its generic atorvastatin on Sept. 19. Each bottle contained 90, 500 or 1,000 tablets, enough to fill prescriptions for three, 17 or 33 patients, respectively, for one month.<\/p>\n

About three weeks later, on Oct. 10, the FDA quantified the risk of using these poor-quality tablets and gave the recall a\u00a0Class II status<\/a>, which means that the medication could cause \u201ctemporary or medically reversible<\/a>\u00a0adverse health consequences.\u201d<\/p>\n

Manufacturers\u00a0must conduct quality tests<\/a>\u00a0on random samples of tablets from every batch they make. These tests make sure the pills contain the correct dosage of the active ingredient, are made to the proper physical specifications and are not contaminated with heavy metals or microbes. If the samples test\u00a0\u201cout of specification\u201d<\/a>\u00a0for any feature, the company must conduct further testing and destroy defective batches, losing the cost of manufacturing them.<\/p>\n

In this case, sample pills\u00a0failed to dissolve properly<\/a>\u00a0when they were tested. Batches manufactured from November 2024 through September 2025 all had this defect.<\/p>\n

As with other drugs, when you swallow atorvastatin, it must\u00a0dissolve before the active ingredient can be absorbed<\/a>\u00a0by the body. It then goes to the liver, where it reduces the blood concentrations of\u00a0low-density lipoproteins<\/a>\u00a0\u2013 also called LDL, or \u201cbad cholesterol.\u201d<\/p>\n

If the drug doesn\u2019t dissolve properly, the amount absorbed by the body is substantially reduced.<\/p>\n

Lowering LDL with atorvastatin<\/a>\u00a0has been shown to reduce cardiovascular events like heart attacks and strokes after a few years by 22%. When almost 30,000 people in a 2021 study stopped taking their\u00a0atorvastatin or other statin for six months<\/a>, the risk of cardiovascular events, deaths and emergency room visits increased between 12% to 15%.<\/p>\n

So, while patients wouldn\u2019t immediately feel a difference if their atorvastatin tablets didn\u2019t dissolve properly, their risk of cardiovascular events would significantly rise.<\/p>\n

What should patients on generic atorvastatin do?<\/p>\n

First, don\u2019t stop taking the medication without talking with your pharmacist or prescriber. Even if you have the recalled pills, taking them is still better than not taking the medicine at all.<\/p>\n

You can determine whether your medication came from Ascend Laboratories by looking at your prescription label.<\/p>\n

Search for the abbreviations\u00a0MFG or MFR<\/a>, which stand for \u201cmanufacturing\u201d or \u201cmanufacturer.\u201d If it says \u201cMFG Ascend\u201d or \u201cMFR Ascend,\u201d that means that Ascend Laboratories supplied the medication.<\/p>\n

The first five letters of a National Drug Code, abbreviated as NDC on the prescription label, also reveal the manufacturer or distributor.\u00a0Ascend products have the number 67877<\/a>.<\/p>\n

If Ascend Laboratories is the distributor, a pharmacist can cross-reference your prescription number to obtain the lot number and compare it with the\u00a0posted lot numbers<\/a>\u00a0on the FDA website for recalled atorvastatin. If your product has been recalled, your pharmacy may have other generic versions of atorvastatin in stock that are not part of this recall.<\/p>\n

Alternatively, the pharmacist can get a new prescription from your health care provider for another\u00a0generic statin drug, such as rosuvastatin<\/a>, which\u00a0works similarly<\/a>.<\/p>\n

A pattern of lapses for overseas manufacturers<\/p>\n

While the defective atorvastatin is distributed by a U.S. company, it is actually manufactured by\u00a0Alkem Laboratories in India<\/a>.<\/p>\n

In fact, many aspects of pharmaceutical drug manufacturing are now occurring overseas, primarily in China and India. This has limited the\u00a0FDA\u2019s ability to provide the oversight<\/a>\u00a0required for drugs sold in the U.S.<\/p>\n

In the 1990s and early 2000s, the FDA\u00a0performed routine surveillance inspections<\/a>\u00a0of U.S. manufacturing plants every three years, but seldom conducted them overseas. In the wake of several high-profile manufacturing quality lapses, including at\u00a0the Indian generic drug giant Ranbaxy Laboratories<\/a>, Congress\u00a0established a funding mechanism<\/a>\u00a0and the FDA established a universal standard for inspecting both U.S. and overseas manufacturers every five years.<\/p>\n

However, the U.S. fell behind with international inspections after COVID-19 shut down international travel, and\u00a0it has yet to catch up<\/a>. Additionally, overseas manufacturers generally get warning of an upcoming inspection, making the process potentially less rigorous than in the U.S.<\/p>\n

A lack of inspections for eye drop manufacturers, especially in India, led to massive recalls in 2023 after a wave of\u00a0rare eye infections<\/a>\u00a0caused some people to lose their eyesight. The problem was traced to widespread unsanitary manufacturing conditions and improper testing for sterility at overseas facilities.<\/p>\n

In 2024,\u00a0eight deaths and multiple hospitalizations<\/a>\u00a0led 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.<\/p>\n

The FDA recently started\u00a0laboratory spot testing<\/a>\u00a0of prescription and over-the-counter drugs arriving in the U.S. to compensate for these limitations. Outside laboratories such as\u00a0Valisure<\/a>\u00a0also do independent testing. Independent testing has caught several dangerous products, but due to limited resources, only a few products can be tested each year.<\/p>\n

In 2023, Alkem Laboratories, which manufactured the currently recalled atorvastatin, had to recall 58,000 bottles of the blood pressure drug\u00a0metoprolol XL<\/a>\u00a0because 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\u00a0blood pressure, diabetes<\/a>\u00a0and\u00a0indigestion drugs<\/a>\u00a0tested between 2019 and 2020, as well as benzene in\u00a0numerous sunscreen and antibacterial gel products<\/a>\u00a0tested between 2020 and early 2025.<\/p>\n

Raising consumer vigilance<\/p>\n

With these growing gaps in oversight, it\u2019s 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\u00a0about sudden loss of drug effectiveness<\/a>\u00a0could help the agency more quickly identify manufacturing issues.<\/p>\n

In 2024, the FDA started\u00a0sharing the inspection burden<\/a>\u00a0with 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.<\/p>\n

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.<\/p>\n

\u00a0<\/p>\n

Originally published in The Conversation.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of\u00a0news coverage\u00a0since\u00a0late October 2025\u00a0about an…\n","protected":false},"author":2,"featured_media":119881,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-119880","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/119880","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=119880"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/119880\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/119881"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=119880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=119880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=119880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}