The valsartan recall and what it did to prices

In July 2018, retail pharmacies paid an average of about 9.5 cents for a 160 mg valsartan tablet, according to the federal government's weekly drug cost survey. By December the figure was 37 cents. Thirty tablets went from $2.86 to $11.09 in five months.

A quality failure set it off. On July 13, 2018, FDA announced voluntary recalls of several valsartan products after a probable human carcinogen, N-nitrosodimethylamine (NDMA), was found in the active ingredient made by one overseas supplier, according to the agency's running log of ARB recall updates¹. Over the next year the recalls spread across makers, strengths and two related blood pressure drugs.

Our explainer on nitrosamine impurities covers the safety side of that episode. This piece follows the money. GxRadar matched FDA's recall timeline against monthly NADAC prices for valsartan 160 mg and losartan 50 mg, using CMS's 2018 NADAC file⁹ and the years after it. Prices for both drugs stayed high for years after the recalls began.

How the recalls unfolded

FDA said in a July 18, 2018, update on the same page¹ that the impurity was "unexpected," that "the agency believes the NDMA is related to changes in the way the active substance was manufactured," and that some of it "may have been in the valsartan-containing products for as long as four years." Three voluntary recalls were under way at that point.

Recalls kept coming. FDA reported a second impurity, N-nitrosodiethylamine (NDEA), in one firm's already recalled products in September 2018. On Sept. 28 it placed the original ingredient maker on an import alert, which FDA said in its update log¹ stopped all of the firm's active ingredient, and finished drugs made with it, from legally entering the United States. In late October, NDEA turned up in irbesartan, which FDA called the first non-valsartan product found to contain it. Losartan recalls began in November 2018, and in March 2019 FDA reported a third impurity, NMBA, in losartan.

FDA's recall reports show the scale. The openFDA enforcement database⁶ holds 122 recall records from 2018 and 2019 whose product descriptions mention valsartan, including combination pills. Of those, 117 cite the impurity, carcinogen or nitrosamine findings. All 117 were Class II, they came from 19 recalling firms, and their recall start dates cluster in July 2018 (42 records), August 2018 (26), November 2018 (16), December 2018 (28) and March 2019 (5). GxRadar's recall tracker shows the effect on the national totals, and our guide to how drug recalls work explains the classes.

What pharmacies paid

Source: GxRadar analysis of CMS NADAC weekly files, generic rates only. Monthly median of weekly values. Monthly from June 2018 to March 2019, quarterly after that.

Two months passed between the first recall and the first move in NADAC. The weekly files show valsartan 160 mg between 9.4 and 9.6 cents through the rate that took effect Aug. 22, 2018, then 14.2 cents from Sept. 19, 30.7 cents from Oct. 17 and 37.0 cents from Nov. 21. NADAC is built from a monthly pharmacy invoice survey, as CMS's methodology¹¹ describes, so it records price changes after pharmacies have paid them.

The number of generic valsartan 160 mg NDCs in the weekly file also fell, from 21 in early June 2018 to 17 by mid-October.

Losartan moved later and more slowly. Its NADAC was flat through the end of 2018 at about 3.3 cents, then climbed through 2019 as losartan recalls mounted, and reached 12.3 cents in September 2020. That was 3.7 times its December 2018 level.

Shortage, and the trade-off FDA made

Pulling contaminated lots took supply off the shelves. In an April 4, 2019, statement³, FDA's commissioner and drug center director wrote: "Removing the affected medications from the market has led to shortages, and since then we've been working to mitigate and prevent shortages as often as possible. Currently, valsartan products are in shortage." In the same statement, FDA said it was not objecting to temporary distribution of specific losartan lots with NMBA above its interim limit while impurity-free supply was built back, and that it expected manufacturers to replenish losartan "in approximately six months."

FDA had already explained that reasoning in a December 2018 update setting interim limits, which said the agency was "tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs," according to the ARB update log¹. Throughout, FDA's public advice to patients was to keep taking their current medicine until a pharmacist provided a replacement or a doctor prescribed a different treatment, and its recall question-and-answer page² noted that not all valsartan, losartan or irbesartan products were affected.

By August 2019, FDA said in a statement on resolving the ARB safety issue⁴ that it had identified 43 ARB medications determined not to contain nitrosamine impurities, and that it expected the number to rise as companies replenished the US supply.

The long road down

Source: GxRadar analysis of CMS NADAC weekly files. Annual averages of monthly medians.

Losartan, with 41 generic NDCs in the Oct. 28, 2026, file, was back near its pre-recall price by 2025. Valsartan took far longer; GxRadar's look at blood pressure generic prices compares it with six others. Its October 2026 NADAC of 10.6 cents was still above the 9.5 cents of July 2018, eight years on, according to the 2026 NADAC file¹⁰, which listed 18 generic NDCs for the 160 mg tablet.

Before the recalls, valsartan's price history was a textbook generic decline. FDA's Drugs@FDA data⁷ date the first generic valsartan tablet approval to June 26, 2014, and nine more were approved in 2015. GxRadar's series starts in September 2014 at $3.36 a tablet; by June 2015 it was 43 cents. Through 2026, 22 generic applications for valsartan tablets had been approved, two of them in 2026. New approvals by year are on the approvals page.

What came after

The nitrosamine problem did not end with ARBs. FDA's nitrosamine information page⁵ now covers other medicines, including metformin, and the agency has since issued guidance on acceptable intake limits for nitrosamine drug substance-related impurities, as GxRadar's account of the 2020 metformin recalls describes. In November 2019 FDA issued a warning letter over manufacturing deviations to a valsartan ingredient plant in India, according to the ARB update log¹; our explainer on inspections and warning letters covers what such letters require.

Valsartan supply is still being reshaped. FDA's shortage data, available through the openFDA drug shortages API⁸, carry a discontinuation notice for valsartan tablets posted Nov. 19, 2025, citing a manufacturer's business decision. The listing covers four presentations. GxRadar's shortage tracker and the valsartan drug page will show any change as new files are posted.