In the event you take cholesterol-lowering medication referred to as statins, you might have observed a flurry of information protection since late October 2025 about an intensive recall of 1000’s of bottles of atorvastatin, the generic model of Lipitor.
Each generic atorvastatin and brand-name Lipitor include the identical energetic ingredient, atorvastatin calcium, and are thought of bioequivalent by the Meals and Drug Administration. This remedy is the No. 1-selling drug within the U.S., with over 115 million prescriptions going to greater than 29 million People.
I’m a medical pharmacologist and pharmacist who has assessed the manufacturing high quality of prescription, over-the-counter and illicit medication, in addition to dietary dietary supplements.
This atorvastatin recall is massive, doubtlessly affecting tons of of 1000’s of sufferers. Nevertheless it’s solely the most recent in a collection of regarding manufacturing points which have come to mild since 2019.
What tablets are being recalled, and why?
Ascend Laboratories, primarily based in New Jersey, initially issued the recall for about 142,000 bottles of its generic atorvastatin on Sept. 19. Every bottle contained 90, 500 or 1,000 tablets, sufficient to fill prescriptions for 3, 17 or 33 sufferers, respectively, for one month.
About three weeks later, on Oct. 10, the FDA quantified the chance of utilizing these poor-quality tablets and gave the recall a Class II standing, which implies that the remedy may trigger “non permanent or medically reversible adversarial well being penalties.”
Producers should conduct high quality assessments on random samples of tablets from each batch they make. These assessments make certain the tablets include the proper dosage of the energetic ingredient, are made to the right bodily specs and should not contaminated with heavy metals or microbes. If the samples check “out of specification” for any function, the corporate should conduct additional testing and destroy faulty batches, shedding the price of manufacturing them.
On this case, pattern tablets didn’t dissolve correctly once they had been examined. Batches manufactured from November 2024 by way of September 2025 all had this defect.
As with different medication, if you swallow atorvastatin, it should dissolve earlier than the energetic ingredient could be absorbed by the physique. It then goes to the liver, the place it reduces the blood concentrations of low-density lipoproteins – additionally referred to as LDL, or “dangerous ldl cholesterol.”
If the drug doesn’t dissolve correctly, the quantity absorbed by the physique is considerably decreased.
Reducing LDL with atorvastatin has been proven to cut back cardiovascular occasions like coronary heart assaults and strokes after a couple of years by 22%. When nearly 30,000 folks in a 2021 research stopped taking their atorvastatin or different statin for six months, the chance of cardiovascular occasions, deaths and emergency room visits elevated between 12% to fifteen%.
So, whereas sufferers wouldn’t instantly really feel a distinction if their atorvastatin tablets didn’t dissolve correctly, their threat of cardiovascular occasions would considerably rise.
What ought to sufferers on generic atorvastatin do?
First, don’t cease taking the remedy with out speaking together with your pharmacist or prescriber. Even when you’ve got the recalled tablets, taking them continues to be higher than not taking the medication in any respect.
You possibly can decide whether or not your remedy got here from Ascend Laboratories by taking a look at your prescription label.
Seek for the abbreviations MFG or MFR, which stand for “manufacturing” or “producer.” If it says “MFG Ascend” or “MFR Ascend,” that implies that Ascend Laboratories equipped the remedy.
The primary 5 letters of a Nationwide Drug Code, abbreviated as NDC on the prescription label, additionally reveal the producer or distributor. Ascend merchandise have the quantity 67877.
If Ascend Laboratories is the distributor, a pharmacist can cross-reference your prescription quantity to acquire the lot quantity and examine it with the posted lot numbers on the FDA web site for recalled atorvastatin. In case your product has been recalled, your pharmacy could produce other generic variations of atorvastatin in inventory that aren’t a part of this recall.
Alternatively, the pharmacist can get a brand new prescription out of your well being care supplier for one more generic statin drug, resembling rosuvastatin, which works equally.
A sample of lapses for abroad producers
Whereas the faulty atorvastatin is distributed by a U.S. firm, it’s truly manufactured by Alkem Laboratories in India.
In truth, many facets of pharmaceutical drug manufacturing at the moment are occurring abroad, primarily in China and India. This has restricted the FDA’s skill to supply the oversight required for medication bought within the U.S.
Within the Nineties and early 2000s, the FDA carried out routine surveillance inspections of U.S. manufacturing vegetation each three years, however seldom performed them abroad. Within the wake of a number of high-profile manufacturing high quality lapses, together with at the Indian generic drug large Ranbaxy Laboratories, Congress established a funding mechanism and the FDA established a common normal for inspecting each U.S. and abroad producers each 5 years.
Nonetheless, the U.S. fell behind with worldwide inspections after COVID-19 shut down worldwide journey, and it has but to catch up. Moreover, abroad producers typically get warning of an upcoming inspection, making the method doubtlessly much less rigorous than within the U.S.
An absence of inspections for eye drop producers, particularly in India, led to huge recollects in 2023 after a wave of uncommon eye infections induced some folks to lose their eyesight. The issue was traced to widespread unsanitary manufacturing situations and improper testing for sterility at abroad services.
In 2024, eight deaths and a number of hospitalizations led an Indian producer, Glenmark Prescription drugs, to recall 47 million potassium chloride extended-release capsules that didn’t dissolve correctly. In February 2025, inspectors discovered that the corporate had falsified high quality outcomes.
The FDA not too long ago began laboratory spot testing of prescription and over-the-counter medication arriving within the U.S. to compensate for these limitations. Outdoors laboratories resembling Valisure additionally do unbiased testing. Impartial testing has caught a number of harmful merchandise, however resulting from restricted sources, only some merchandise could be examined annually.
In 2023, Alkem Laboratories, which manufactured the at the moment recalled atorvastatin, needed to recall 58,000 bottles of the blood stress drug metoprolol XL as a result of the tablets additionally didn’t correctly dissolve. Spot testing additionally led to widespread recollects after FDA and Valisure laboratories discovered cancer-causing chemical substances referred to as nitrosamines in some blood stress, diabetes and indigestion medication examined between 2019 and 2020, in addition to benzene in quite a few sunscreen and antibacterial gel merchandise examined between 2020 and early 2025.
Elevating shopper vigilance
With these rising gaps in oversight, it’s affordable to be conscious of modifications in how a specific remedy impacts you. In case your prescription drug abruptly stops working, it is likely to be as a result of that exact batch of the remedy was not manufactured correctly. Alerting the FDA about sudden lack of drug effectiveness may assist the company extra shortly determine manufacturing points.
In 2024, the FDA began sharing the inspection burden with different regulatory businesses just like the European Medicines Company for the European Union. Such coordinated efforts may result in much less duplication and a bump in inspections of abroad producers.
Within the meantime, nonetheless, shoppers are largely on the mercy of spotty inspections and testing, and infrequently hear about issues until poorly manufactured medication trigger widespread adversarial occasions.
This text is republished from The Dialog, a nonprofit, unbiased information group bringing you details and reliable evaluation that will help you make sense of our complicated world. It was written by: C. Michael White, College of Connecticut
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C. Michael White doesn’t work for, seek the advice of, personal shares in or obtain funding from any firm or group that might profit from this text, and has disclosed no related affiliations past their educational appointment.
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