Common Blood Pressure Drug Recalled Nationwide, FDA Says

An employee at a Florida pharmacy, in this file photo. file photo, Joe Raedle/Getty Images

Novartis Pharmaceuticals Corporation recalled some heart failure and high blood pressure medication due to potency issues, according to the Food and Drug Administration’s website.

The recall affects one lot of Diovan, Novartis’ valsartan brand, according to a report issued last week. The lot includes 160-milligram tablets in 90-count bottles, with the lot number AV5913C, and an expiration date of June 2027.

The drug is prescription-only and manufactured by North Carolina-based Patheon Manufacturing Services LLC and distributed by Novartis, a multinational pharmaceutical company that is one of the largest in the world.

According to the FDA notice, the reason for the recall is due to “failed dissolution specifications,” meaning that the pills may not dissolve correctly in the body when ingested.

The recall was initiated on Aug. 4, while the FDA later classified the recall as Class II, which it describes 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.”

The notice did not say how many bottles of the medication were impacted but added that it is a nationwide recall.

The Mayo Clinic says that valsartan is a type of angiotensin II receptor blocker, which stops “a substance in the body that causes blood vessels to tighten.”

It can be used by itself or together with other medicines to treat high blood pressure, heart failure, and left ventricular failure following a heart attack.

Valsartan is commonly prescribed, according to drug database ClinCalc, with around 10.9 million patients taking the medication in 2024.

In 2018, in a separate instance, global health agencies and the FDA launched significant recalls of valsartan after it was linked to contamination produced by Zhejiang Huahai Pharmaceuticals, located in Linhai, China. The medications were discovered to have high levels of N-nitrosodimethylamine, which can be carcinogenic.

Other Heart Drug Recalls

Earlier this month, India-based drug manufacturer Alkem Laboratories Ltd. said it was recalling more than 5,600 packages of a heart and blood-thinning medication, dabigatran etexilate, according to an FDA notice.

The recall was due to “failed impurity/degradation specification” in a tested batch of the drug, according to the notice.

Amlodipine and olmesartan medoxomil tablets—in 10 mg and 20 mg doses, respectively—are being recalled nationwide, according to a separate FDA notice in July.

The product was manufactured by Alkem Laboratories Ltd. and distributed by New Jersey-based Ascend Laboratories LLC, according to the report, which added that 6,192 bottles are affected by the action.