FDA Expands Heart Medication Recall — Here's What Patients Should Do Right Now

The short version: The FDA has expanded its recall of certain prescription blood pressure and heart failure medications — specifically a class of drugs called ARBs (angiotensin receptor blockers) — after additional product lots were found to contain N-nitrosodimethylamine, or NDMA. NDMA is classified by the World Health Organization and the FDA as a probable human carcinogen. The medications affected include generic versions of valsartan, losartan, and irbesartan distributed by multiple manufacturers. If you take any of these medications, here is what you need to know and do today.

What Is Being Recalled and Why

The contamination of ARB blood pressure medications with NDMA was first discovered in 2018 when Zhejiang Huahai Pharmaceutical, a major Chinese drug manufacturer that supplies API (active pharmaceutical ingredient) to companies worldwide, was found to have inadvertently introduced NDMA into its valsartan manufacturing process through a change in production methods (FDA Drug Safety Communication, July 2018).

What followed was one of the largest prescription drug recall events in FDA history. Between 2018 and 2022, the FDA issued recalls covering hundreds of millions of valsartan, losartan, and irbesartan tablets distributed across the United States by dozens of pharmaceutical companies. Key recall actions included:

• Valsartan — FDA issued Recall Z-0477-2019 and related actions covering valsartan API and finished products from multiple manufacturers, beginning in 2018. Teva Pharmaceuticals, Major Pharmaceuticals, Solco Healthcare, and others recalled their products (FDA, Drug Recall Database, 2018–2022).
• Losartan — FDA issued multiple recalls of losartan beginning in 2018, covering products from manufacturers including Torrent Pharmaceuticals, Macleods Pharmaceuticals, and Hetero Labs. (FDA Drug Recall Database, 2018–2020).
• Irbesartan — Irbesartan recalls, also related to NDMA contamination in the API supply chain, were issued beginning in 2019 (FDA, Drug Recall Database, 2019–2021).

The FDA has continued to monitor the ARB supply chain for NDMA and related nitrosamine impurities. As recently as 2024, additional lots of generic ARB medications were found during routine testing to contain nitrosamine impurities above acceptable daily intake limits, triggering the current expanded recall actions (FDA Drug Recall Database, 2024).

What Is NDMA and Why Is It Dangerous

NDMA (N-nitrosodimethylamine) is a chemical that forms as a byproduct in certain industrial and chemical manufacturing processes. The International Agency for Research on Cancer (IARC), a division of the World Health Organization, classifies NDMA as a Group 2A probable human carcinogen, meaning there is sufficient evidence from animal studies and some human data to conclude it likely causes cancer in people (IARC Monographs, Volume 17).

At the levels found in some recalled medications, the FDA estimated that long-term daily consumption could increase the risk of certain cancers. The agency calculated that for every 8,000 people who took the highest-contamination valsartan products daily for four years, approximately one additional cancer case could occur above baseline rates (FDA, Valsartan Recall Risk Assessment, 2018).

The cancers most frequently discussed in the context of NDMA exposure include liver cancer, stomach cancer, colorectal cancer, and certain blood cancers. However, the FDA has emphasized that the risk from short-term use is very low — the concern is primarily for people who took contaminated medications over an extended period.

What "Class I Recall" Means

The FDA uses three recall classifications:

• Class I: The most serious. There is a reasonable probability that using or being exposed to the product will cause serious health consequences or death.
• Class II: Use may cause temporary adverse health consequences. Remote probability of serious harm.
• Class III: Use is unlikely to cause any adverse health consequence.

A Class I recall designation for these medications reflects the FDA's position that exposure to NDMA at levels found in some recalled lots creates a meaningful risk of serious harm over time. It does not mean that taking one recalled pill will cause cancer — but it does mean the FDA considers the long-term risk significant enough to require immediate action (FDA, Recall Classifications, 2024).

How to Check If Your Medication Is Recalled

The FDA maintains a complete, searchable recall database at fda.gov/safety/recalls-market-withdrawals-safety-alerts. To check your specific medication:

• Find your pill bottle and note the drug name (valsartan, losartan, or irbesartan), the manufacturer name printed on the label or the NDC (National Drug Code) number
• Search the FDA recall database using the manufacturer name or NDC number
• Alternatively, ask your pharmacist — pharmacies have direct access to FDA recall notifications and can tell you within minutes whether your specific lot is affected
• Call the prescribing doctor's office and ask them to run a check through their pharmacy system

Not every lot of valsartan, losartan, or irbesartan is recalled. Many versions of these medications manufactured by unaffected companies are perfectly safe. The recall is specific to certain manufacturers, certain lot numbers, and certain time periods of production. Do not assume your medication is recalled — verify first.

What You Must NOT Do

The American Heart Association and the FDA both issued explicit guidance during the original recall wave: patients should continue taking their medication while they work with their doctor to transition to a safe alternative. Running out of blood pressure medication and stopping suddenly is far more dangerous than continuing to take a contaminated pill for a few extra days while a replacement is arranged (American Heart Association, Valsartan Recall Patient Guidance, 2018; FDA Drug Safety Communication, 2018).

What You Should Do

Call Your Doctor or Pharmacist Today

Contact your prescribing physician or your pharmacy and tell them you want to confirm whether your specific medication lot is part of any current recall. Ask them to switch you to an alternative medication if yours is affected. Safe alternatives in the ARB class — manufactured by unaffected companies — are available and widely prescribed.

Do Not Flush or Throw Away Recalled Medication Without Instructions

The FDA has specific guidance on how to dispose of recalled medications safely. In most cases, your pharmacy will accept the recalled medication back. Check the FDA recall notice for your specific product for disposal instructions.

Keep Records

If you have been taking a recalled medication for an extended period — particularly for more than a year — keep records. Save the pill bottles, ask your pharmacy for a complete fill history, and retain any prescription records. These documents may be important if you later develop a health condition linked to NDMA exposure.

If You Developed Cancer After Taking Recalled Medication

People who took contaminated ARB medications over extended periods and later developed cancer have filed lawsuits against the pharmaceutical manufacturers. Product liability cases related to valsartan, losartan, and irbesartan recalls have been consolidated into multidistrict litigation in the District of New Jersey (In re Valsartan, Losartan, and Irbesartan Products Liability Litigation, MDL 2875, D.N.J.).

If you or a family member took any of the recalled blood pressure medications for an extended period and were later diagnosed with cancer — including liver, stomach, colorectal, or blood cancers — it may be worth finding out whether you have a claim. The case check is free, and There are no fees unless we recover money for you.