Every valsartan product currently sold in the United States has been cleared by the FDA and must meet strict limits for nitrosamine impurities, the contaminants that triggered massive recalls starting in 2018. If your pharmacy filled a valsartan prescription today, the manufacturer has passed testing requirements that did not exist before the contamination crisis. That said, understanding which companies make valsartan, what went wrong, and how to verify your own medication can give you real peace of mind.
What Happened With Valsartan Contamination
In 2018, regulators discovered that certain batches of valsartan contained NDMA and NDEA, two chemicals classified as probable human carcinogens. The problem traced back to a single Chinese manufacturer, Zhejiang Huahai Pharmaceutical, which supplied the active ingredient to many generic drugmakers worldwide. The contamination wasn’t a packaging error or a one-off accident. It was baked into the manufacturing chemistry itself.
Specifically, Huahai had changed its production process for a key step in building the valsartan molecule (the formation of its tetrazole ring). The new method used a solvent called dimethylformamide, which naturally contains trace amounts of a reactive byproduct. When that byproduct came into contact with sodium nitrite, used later in the process to neutralize leftover chemicals, it created NDMA. In other words, the contamination was an unintended side effect of a cost-saving manufacturing change, and it had likely been happening for years before anyone tested for it.
The recalls were enormous. Teva Pharmaceuticals, for example, recalled 80 lots of valsartan tablets distributed under the Actavis label, all because they had sourced their active ingredient from Huahai. Multiple other companies followed. The FDA has since confirmed that the overall cancer risk to any individual patient was very low, but the scale of the problem forced a complete overhaul of how these drugs are tested and regulated.
FDA-Approved Valsartan Manufacturers Today
As of the December 2025 FDA Approved Drug Product List, the following companies hold active approvals to sell valsartan in the United States:
- Alembic Pharmaceuticals
- Amneal Pharmaceuticals of New York
- Aurobindo Pharma
- Dr. Reddy’s Laboratories
- Macleods Pharmaceuticals
- Mylan Pharmaceuticals
- PH Health (formerly Perrigo)
- Rising Pharma Holdings
- TP ANDA Holdings
- Watson Laboratories
- Zydus Lifesciences
For the combination product sacubitril/valsartan (sold as Entresto), Alkem Laboratories and Takeda Pharmaceuticals also appear on the approved list.
Every one of these manufacturers must now demonstrate that their product falls below the FDA’s acceptable daily intake limits for nitrosamine impurities: no more than 96 nanograms of NDMA and no more than 26.5 nanograms of NDEA per day. These thresholds represent the level at which, even with a lifetime of daily exposure, the additional cancer risk is considered negligible. Products that exceed these limits cannot legally remain on the market.
How to Verify Your Specific Medication
Generic drugs from different manufacturers can look different, and your pharmacy may switch suppliers between refills. The most reliable way to identify who made your valsartan is the NDC (National Drug Code) number printed on the prescription label. This 10- or 11-digit code identifies the manufacturer, the specific drug product, and the package size. You can search it on the FDA’s DailyMed website (dailymed.nlm.nih.gov) to pull up the full product labeling, including the company name and manufacturing details.
If your medication looks different from your last refill, or if you simply want confirmation, your pharmacist can tell you the manufacturer and confirm the NDC. This is a routine question they handle regularly.
Brand-Name Diovan vs. Generics
Diovan, the original brand-name valsartan made by Novartis, was not part of the recalls. The contamination affected specific generic manufacturers that sourced their active ingredient from Huahai. However, Diovan’s patent expired years ago, and the brand-name version is now rarely dispensed in the U.S. because generics are far less expensive. If cost is not a concern and you want the brand name, you can ask your doctor to write the prescription accordingly, though there is no safety advantage today given current testing requirements.
Other Blood Pressure Medications in the Same Class
Valsartan belongs to a group of drugs called ARBs (angiotensin receptor blockers). The nitrosamine problem was not unique to valsartan. Certain batches of losartan and irbesartan were also recalled for the same type of contamination. However, the FDA identified at least 40 ARB medications across the class that contained no detectable nitrosamine impurities at all. Other ARBs like olmesartan, telmisartan, and candesartan were largely unaffected by the recalls.
If the history of valsartan contamination concerns you, switching to a different ARB is a conversation worth having with your prescriber. The drugs in this class work through the same mechanism and are generally interchangeable for blood pressure control, though dosing differs. Your doctor can determine whether an alternative makes sense for your specific situation.
Why the Risk Is Different Now
Before 2018, no one routinely tested blood pressure medications for nitrosamine impurities. The contamination in valsartan likely persisted for years undetected. That regulatory gap has closed. The FDA now requires manufacturers to test for these specific impurities before releasing batches, and the European Medicines Agency has imposed similar obligations, requiring that every batch of finished product meets quality standards that explicitly include nitrosamine screening.
The manufacturing processes themselves have also changed. The chemical pathway that generated NDMA at Huahai, combining certain solvents with nitrite-based quenching agents, is now a known risk that manufacturers must design around or test for. Companies that source active ingredients from third-party suppliers are responsible for verifying the purity of what they receive, not just the tablets they produce.
None of this means contamination can never recur in any drug. But the specific failure that caused the valsartan crisis, an unmonitored process change at a single supplier cascading through the global generic drug supply, triggered exactly the kind of systemic fix that makes a repeat far less likely. If your valsartan is currently on a U.S. pharmacy shelf, it has passed testing that would have caught the original problem years earlier.