Only 50% of the Americans eligible for medications to lower cholesterol are actually taking them, according to 2025 research from experts at Johns Hopkins. Still, the number of Americans taking statins continues to rise—and now two nationwide recall announcements from the U.S. Food and Drug Administration (FDA) expose problems for them to beware of.

The first, a January 20 recall from pharmaceutical company AvKARE, involves 7,991 50-tablet cartons of 10-milligram Rosuvastatin tablets. The Mayo Clinic explains this drug works to lower “bad” cholesterol (LDL) and triglycerides while also increasing “good” cholesterol (HDL). Crestor happens to be the brand name for one rosuvastatin product, though it is not involved in this recall and is made by AstraZeneca.

“Out of specification for dissolution” is the stated reason behind the Rosuvastatin recall, likely meaning the drugs did not properly dissolve during testing, which could impact how they are absorbed in the body.

The second recall affects 22,896 bottles of 1-gram Icosapent Ethyl capsules distributed by Zydus Pharmaceuticals (USA) Inc, with each bottle contains 120 capsules. Cleveland Clinic experts say Icosapent Ethyl capsules are prescribed to treat high triglyceride levels, though the drug may also be used to lower the risk of heart attack or stroke.

Made public on January 22, the recalling reason behind the Icosapent Ethyl capsules describes a scenario where taking the drug could result in certain side effects. The report first described the drug as “subpotent,” indicating the capsules do not provide the promised strength. The FDA goes on to describe the problem as: “Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.” [sic]

The FDA also provided the following details for each recall:

Rosuvastatin Tablets, USP, 10 milligrams (mg)

  • 50 Tablets (5 x 10) Unit Dose per carton, Rx only
  • Lot #: 49124
  • Expiration Date: 12/31/2026
  • Manufactured for: AvKARE, Pulaski, TN 38478
  • National Drug Code (NDC): 50268-709-15
  • 7,991 5×10 cartons

Icosapent Ethyl capsules, 1 gram

  • 120-count bottles, Rx only
  • Lot # and Expiration Dates: S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
  • Manufactured by: Softgel Healthcare Pvt. Ltd., India
  • Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
  • National Drug Code (NDC): 70710-1592-07
  • 22,896 bottles

Both recalls have been categorized as Class II events by the FDA, meaning the agency has determined both situations “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

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