Novartis Recalls One Lot of Diovan Blood Pressure Pills Over Dissolution Failure

Novartis Pharmaceuticals Corporation has recalled one lot of its brand-name blood pressure drug Diovan after the pills failed dissolution testing, according to a recall notice posted on the FDA's website.

The affected product is Diovan (valsartan) 160 milligram tablets, sold in 90-count bottles, lot number AV5913C, with an expiration date of June 2027. The tablets were manufactured by Patheon Manufacturing Services LLC in North Carolina and distributed by Novartis from its New Jersey office.

Novartis initiated the recall voluntarily on August 4. The FDA classified it as Class II on August 7, according to both The Epoch Times, via ZeroHedge, and Yahoo's report on the recall. A Class II recall, per the FDA's own definition, covers situations where a product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." That is a step below the FDA's most severe Class I designation.

The FDA notice lists the reason for the recall as "Failed Dissolution Specifications." In plain terms, the pills didn't dissolve the way they're supposed to during quality testing. If a pill doesn't dissolve properly, the body may not absorb the medication correctly, which can affect how well it controls blood pressure or heart failure symptoms.

Neither the FDA notice nor Novartis has said how many bottles are affected. Both ZeroHedge's and Yahoo's coverage note the quantity is listed as "not available" in the FDA's own report. Patients have no way to know how widespread the affected lot is, only that it's being pulled everywhere it was distributed, as the recall is described as nationwide.

Valsartan isn't a niche drug. ClinCalc, a drug-use database cited by The Epoch Times, estimates around 10.9 million patients took valsartan in 2024. It's a standard angiotensin II receptor blocker, prescribed to relax blood vessels in patients with high blood pressure, heart failure, or left ventricular failure following a heart attack, according to the Mayo Clinic.

This recall is also notable because it hits the brand-name product, not a generic. Yahoo's report specifically flags that distinction: recalls in this drug class often involve generic manufacturers, not the company whose name is on the label.

This isn't valsartan's first brush with a nationwide recall. In 2018, the FDA and global health agencies pulled valsartan products linked to Zhejiang Huahai Pharmaceuticals, a manufacturer based in Linhai, China, after testing found elevated levels of N-nitrosodimethylamine, a compound that can be carcinogenic. That recall involved contamination.

The current recall is different. It's a single lot, one dosage strength, tied to a dissolution testing failure at a domestic U.S. facility, not a carcinogen contamination event. Both ZeroHedge's and Yahoo's coverage separate the current dissolution issue from the 2018 contamination scandal, even while noting the history.

Patients who take Diovan should check their bottle for lot number AV5913C and the June 2027 expiration date.

Novartis has not released a public statement beyond what's captured in the FDA's recall database, and neither the company nor the FDA has indicated whether additional lots or dosage strengths could be affected. Until Novartis or the FDA discloses total bottle counts, the scope of how many patients were actually affected remains an open question.