Yes, valsartan is safe to take now. The contamination problem that triggered widespread recalls in 2018 and 2019 has been resolved, and valsartan currently on pharmacy shelves is manufactured under stricter testing requirements than before the crisis. If you’re filling a new prescription or still taking valsartan, the supply today is not the same supply that caused concern years ago.
What Happened With the Recalls
Starting in mid-2018, the FDA discovered that certain batches of valsartan contained a chemical called NDMA, a probable carcinogen that can form as a byproduct during drug manufacturing. The contamination was traced to specific overseas factories that supplied the raw ingredient to multiple pharmaceutical companies. Over the following months, recalls expanded to include other blood pressure drugs in the same class, including losartan and irbesartan.
All recalled lots had expiration dates in 2018 and 2019, meaning those products have long since cleared the supply chain. The FDA’s recall list, last updated in October 2021, is now a historical record rather than an active warning. There are no active valsartan recalls in effect today.
How Manufacturing Standards Changed
The contamination crisis prompted the FDA to develop specific laboratory methods for detecting NDMA in valsartan products. Manufacturers must now test for nitrosamine impurities before releasing batches for sale. The FDA’s validated testing method can detect NDMA at levels as low as 0.05 parts per million, well below the threshold that would pose a health concern.
The FDA also established a formal acceptable daily intake limit for NDMA at 96 nanograms per day. This number represents the level at or below which the impurity poses no meaningful safety risk to patients, even with long-term use. Any batch exceeding this limit would be flagged and pulled from the market. These safeguards did not exist before 2018, so in a real sense, valsartan manufacturing is more tightly monitored now than it was before the problem surfaced.
Did the Contamination Cause Cancer?
This is the question that lingers for people who took valsartan during the affected period. A large study published in the Journal of the American Heart Association examined 1.4 million valsartan users and found that overall cancer risk was not increased among those who took contaminated batches. The adjusted hazard ratio was 0.99, essentially identical to the unexposed group.
The study did find small, statistically significant increases in two specific cancers: liver cancer (about 3.7 extra cases per 100,000 people per year) and melanoma (about 5.8 extra cases per 100,000 people per year). To put that in perspective, the baseline rate of liver cancer in the unexposed group was roughly 30 per 100,000 person-years, and the contaminated group’s rate was about 34. The researchers found no dose-response relationship, meaning people who took higher doses of valsartan didn’t have proportionally higher cancer rates. No other cancer types showed increased risk.
If you took contaminated valsartan in 2018 or 2019, these numbers suggest the absolute increase in risk was very small. It does not mean you will develop cancer. It means that across a huge population, a handful of additional cases appeared, and even that finding could be influenced by other factors the study couldn’t fully control for.
Common Side Effects of Valsartan
Separate from the contamination issue, valsartan has a well-established side effect profile. For people taking it for high blood pressure, it’s generally well tolerated. In clinical trials, the most common complaints were fatigue (2% of patients vs. 1% on placebo) and abdominal pain (2% vs. 1%). These are modest differences.
Side effects are more noticeable when valsartan is used for heart failure. Dizziness affects about 17% of heart failure patients on valsartan compared to 9% on placebo. Low blood pressure occurs in about 7% versus 2%. Diarrhea, joint pain, and fatigue each occur in a small percentage of patients. One notable advantage over older blood pressure drugs like captopril: valsartan causes significantly less cough. In post-heart attack trials, only 0.6% of valsartan patients stopped the drug due to cough, compared to 2.5% on captopril.
Valsartan should not be taken during pregnancy, as it can harm the developing fetus. It’s also not appropriate for anyone who has previously experienced angioedema (severe swelling of the face, lips, or throat) or who has a known allergy to any ingredient in the formulation.
Alternatives if You’re Still Uneasy
If the recall history makes you uncomfortable, that’s understandable, and there are plenty of other options for managing blood pressure. Within the same drug class, losartan, olmesartan, and candesartan work through the same mechanism. Outside the class, common alternatives include amlodipine (a calcium channel blocker), lisinopril (an ACE inhibitor), metoprolol (a beta-blocker), and hydrochlorothiazide (a diuretic). Each has its own side effect profile and may be better or worse suited to your situation depending on other health conditions you have.
That said, switching medications solely because of a resolved contamination issue means trading a drug that’s working for you for one that might cause new side effects or be less effective at your current dose. The valsartan on shelves today meets testing standards that specifically screen for the contaminants that caused the original problem.
How to Verify Your Prescription
If you want to confirm your current valsartan isn’t part of any historical recall, check the lot number printed on your prescription bottle. You can cross-reference it against the FDA’s archived recall list at fda.gov. In practice, any valsartan dispensed in the last several years would not be from a recalled batch, since all affected lots expired by late 2019 at the latest. Your pharmacist can also confirm that your specific manufacturer and lot number are clear.