Nearly 22,000 bottles of a type of blood pressure and heart medication have been recalled because the medications were too potent, according to a recent report published by the Food and Drug Administration.
West Virginia-based Vitaris stated in the FDA notice that it’s recalling tablets of its generic telmisartan and amlodipine, in 40-milligram and 5-milligram doses, respectively. The prescription-only medication is contained in 30-count bottles, it stated.
The drug was manufactured for West Virginia-based Mylan Pharmaceuticals, and it was made in India, the enforcement report states. The medication was distributed across the United States.
The recall reason was listed as “Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications,” according to the notice. No other details were provided.
The FDA classified the recall as Class III, or what the agency defines as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.” It’s the lowest-risk level in the agency’s three-tiered recall classification system.
No statement was issued for the recall, and the drug companies and the FDA did not say what consumers should do with the medication.
The FDA stated on its website that “for class II and III recalls, consumers can generally continue taking the medicine unless the recalling company provides other instructions.”
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine,” the federal health agency stated.
According to the notice, lot numbers 3228113, 3228114, and 3228115 were recalled. They have an expiration date of Oct. 31, 2026.
Two other lots with numbers 3228120 and 3228121 were also recalled, with an expiration date of Nov. 30, 2026, the report states.
Mayo Clinic officials said that telmisartan is an angiotensin II receptor blocker that works to prevent the body’s blood vessels from tightening, causing them to relax and lowering blood pressure. It also helps increase the flow of blood and oxygen to the heart.
Telmisartan is a somewhat commonly used medication, with an estimated 614,000 patients using the drug in the United States in 2024, according to drug database ClinCalc.
Amlodipine is used to treat high blood pressure and chest pain caused by angina, and it also works to lower the risk of hospitalization for angina and heart surgery, according to the clinic. It is a calcium channel blocker, which affects calcium’s movement into the heart and blood vessels, which in turn lowers blood pressure.
Vitaris recalled 21,600 bottles of the tablets on Oct. 1, but it was only classified by the FDA last week. The FDA posted the recall notice to its website during the week of Oct. 21.
