It's a drug used by nearly half of seniors to lower heart risk, and a lower-cost alternative to a widely used brand name.
Right now, 45% of U.S. adults between the ages of 60 and 79 take statins, a lipid-lowering prescription drug indicated to treat high levels of LDL or “bad” cholesterol. In fact, national data shows statins are the most commonly-prescribed medication among older adults, who are at outsized risk of cardiovascular events including heart attack and stroke.
While statins help tens of millions of Americans lower their risk of death and disability each year, their ubiquity means that drug recalls can have far-reaching effects. One ongoing nationwide incident, updated on October 10 by the U.S. Food and Drug Administration (FDA), affects at least 141,984 bottles of one of the most common types of statins, Atorvastatin Calcium Tablets. This happens to be the generic name for Lipitor, which the Cleveland Clinic explains is a drug that works by blocking a particular liver enzyme that the body needs to produce cholesterol.
The tablets were manufactured by Alkem Laboratories, Ltd. in India, and distributed by Ascend Laboratories, LLC, in Parsippany, NJ. The FDA’s notice only listed a product quantity for the 10-milligram dosages—the other amounts are undisclosed. This means that the true quantity of affected products is unknown, but is likely significantly higher than the amount currently listed.
Ask your doctor or pharmacist about switching to a safer option—the Cleveland Clinic says: “There’s no safe way to stop taking statins without first consulting with your healthcare provider.” Consumers can identify the affected product by the following dosages, NDC numbers, lot codes, and expiration dates:
10-milligram (mg) Tablets
- NDC: 67877-511-90 (90-count) or 67877-511-05 (500-count)
- Amount: 141,984 bottles
- Recalled Lots:
- 25141249 – Exp. Feb 2027
- 24144938 – Exp. Nov 2026
- 24144868 – Exp. Nov 2026
- 24144867 – Exp. Nov 2026
- 24144458 – Exp. Sep 2026
- 24143994 – Exp. Sep 2026
- 24142987 – Exp. Jul 2026
- 24143316 – Exp. Jul 2026
20-mg Tablets
- NDC: 67877-512-90 (90-count), 512-05 (500-count), or 512-10 (1,000-count)
- Amount: Undisclosed
- Recalled Lots:
- 25140150, 25140173, 25140172 – Exp. Dec 2026
- 24144720, 24144798 – Exp. Nov 2026
- 24144692 – Exp. Oct 2026
- 24143755, 24143913, 24143754 – Exp. Aug 2026
- 24143047 — Exp. Jun 2026
- 24142936 — Exp. Jul 2026
40-mg Tablets
- NDC: 67877-513-90 (90-count), 513-05 (500-count), or 513-10 (1,000-count)
- Amount: Undisclosed
- Recalled Lots:
- 25140933 – Exp. Feb 2027
- 25140477 – Exp. Dec 2026
- 24144254 – Exp. Oct 2026
- 24144163, 24143995 – Exp. Sep 2026
80-mg Tablets
- NDC: 67877-514-90 (90-count) or 514-05 (500-count)
- Amount: Undisclosed
- Recalled Lots:
- 25140249, 25140247 – Exp. Dec 2026
- 24144999, 24144942, 24144845, 24144713 – Exp. Nov 2026
- 24144652 – Exp. Oct 2026
- 24143898, 24143412, 24143582 – Exp. Aug 2026
The recall was initiated as the result of failed dissolution specifications, meaning that when the drugs were tested, they did not dissolve at the expected rate. As an FDA report explains, this could impact a patient’s ability to absorb the drug properly, in turn lowering its efficacy.
This prompted the FDA to designate the event a Class II incident, which they define as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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