What Is the Valsartan Recall?
Valsartan recall refers to the large-scale withdrawal of certain batches of valsartan, a medication used to treat high blood pressure and heart failure, after contamination with nitrosamines—chemical compounds known to increase the risk of cancer.
The issue first came to light in July 2018, when global health regulators detected N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in some valsartan products made with active ingredients sourced from Zhejiang Huahai Pharmaceutical Co. Ltd. in China.
These impurities are considered probable human carcinogens, leading to worldwide recalls involving multiple manufacturers and distributors.
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Why Was Valsartan Recalled?
1. Discovery of NDMA and NDEA Contamination
NDMA and NDEA are nitrosamine impurities that can form during specific chemical reactions in drug manufacturing. In valsartan’s case, a change in the manufacturing process at certain factories introduced conditions where these contaminants formed inadvertently.
2. Regulatory Response
The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued urgent recalls and began rigorous testing of all angiotensin II receptor blockers (ARBs), including losartan and irbesartan, to ensure other products were not contaminated.
Timeline of the Valsartan Recall
| Year | Key Event |
|---|---|
| 2018 | First detection of NDMA in valsartan API from Zhejiang Huahai; initial recalls begin in Europe and the U.S. |
| 2019 | Recall expands to include NDEA contamination and other ARBs like losartan and irbesartan. |
| 2020–2021 | Ongoing recalls of combination drugs (e.g., valsartan/amlodipine, valsartan/HCTZ). |
| 2022–2024 | FDA continues nitrosamine risk assessments and mandates stricter manufacturing oversight. |
| 2025 | Regulators reaffirm safety of unaffected valsartan lots; litigation and settlements continue. |
Which Products Were Affected?
The recall did not affect all valsartan products—only specific batches produced or repackaged by certain companies.
Manufacturers involved at different points included:
- Aurobindo Pharma USA, Inc.
- Torrent Pharmaceuticals
- Mylan Pharmaceuticals
- Teva Pharmaceuticals
- Solco Healthcare
- Hetero Labs Limited
- Major Pharmaceuticals
- Camber Pharmaceuticals
If your prescription label shows any of these companies, check the National Drug Code (NDC) and lot number against the official FDA recall database.
How to Check if Your Valsartan Is Recalled
- Look at your medication label.
Find the manufacturer name, NDC number, and lot number printed on the prescription bottle or packaging. - Use the FDA Recall Database.
Visit the FDA Valsartan Recall List and search by NDC or manufacturer. - Ask your pharmacist.
Pharmacists can verify whether your specific batch was recalled and offer a replacement or generic from an unaffected lot. - Don’t stop taking your medication suddenly.
Abrupt discontinuation can cause dangerous spikes in blood pressure or heart complications. Always consult your doctor first.
Health Risks Associated with Contaminated Valsartan
1. Cancer Concerns
NDMA and NDEA exposure has been linked to an increased risk of certain cancers, including:
- Liver cancer
- Stomach cancer
- Kidney cancer
- Colorectal cancer
However, the FDA estimates that the absolute risk is relatively low, particularly for patients exposed short-term. The estimated additional lifetime risk of cancer is about 1 in 8,000 for those who took the highest contaminated doses daily for four years.
2. Short-Term Health Effects
Most people will not experience immediate symptoms from exposure. The primary concern remains long-term carcinogenic risk rather than acute toxicity.
What You Should Do If You Take Valsartan
- Step 1: Do not panic or abruptly stop your medication.
Stopping suddenly can raise your blood pressure and increase heart attack risk. - Step 2: Check if your product is affected.
Use the FDA recall database or call your pharmacy. - Step 3: Consult your doctor for safe alternatives.
Options may include switching to another ARB (like losartan or olmesartan) or a different blood pressure drug class. - Step 4: Return affected medicine properly.
Pharmacies often have disposal programs or return instructions. - Step 5: Report adverse effects.
Use the FDA MedWatch form if you suspect side effects from contaminated medication.
Lawsuits and Legal Actions
Following the recall, thousands of Valsartan lawsuits were filed across the U.S. and globally. Plaintiffs claim that long-term use of contaminated drugs led to cancer diagnoses and emotional distress.
1. Valsartan MDL Litigation
All U.S. federal cases were consolidated into a Multidistrict Litigation (MDL) in New Jersey. The MDL streamlines discovery and settlement negotiations across multiple manufacturers and distributors.
2. Current Status
As of 2025, litigation remains ongoing. Some settlements and class actions are being negotiated, and law firms continue to accept clients who took recalled lots and later developed qualifying cancers.
Regulatory and Manufacturing Reforms
In the wake of the valsartan contamination, global regulators strengthened pharmaceutical manufacturing oversight.
1. FDA and EMA Response
- Introduced stricter impurity testing requirements for nitrosamines across all medications.
- Required manufacturers to review chemical synthesis routes for risk factors.
- Implemented new acceptable daily intake (ADI) limits for NDMA and NDEA.
2. Industry-Wide Changes
- Manufacturers must now perform routine nitrosamine testing on APIs.
- Quality control documentation is more transparent and subject to unannounced inspections.
- Regulators maintain real-time public databases for drug recalls to enhance transparency.
Alternatives to Valsartan
If your valsartan product was recalled or discontinued, your doctor may prescribe another angiotensin II receptor blocker (ARB) or switch you to a different class of blood pressure medications, such as:
| Drug Class | Common Examples | Notes |
|---|---|---|
| ARB | Losartan, Olmesartan, Telmisartan | Similar effectiveness with improved manufacturing oversight. |
| ACE Inhibitor | Lisinopril, Enalapril | May cause cough in some patients. |
| Calcium Channel Blocker | Amlodipine | Good for combination therapy. |
| Thiazide Diuretic | Hydrochlorothiazide | Often used in mild hypertension cases. |
Always make medication changes under medical supervision.
Frequently Asked Questions (FAQ)
Is all valsartan recalled?
No. Only specific lots from certain manufacturers were affected. Many valsartan products remain safe and on the market.
Should I stop taking valsartan immediately?
No. You should never stop a prescribed medication without consulting your healthcare provider. Uncontrolled blood pressure can lead to serious health problems.
How do I know if my valsartan is contaminated?
Check the FDA or EMA official recall list using your NDC or lot number. Your pharmacist can help verify this.
Can contaminated valsartan cause cancer?
Long-term exposure to high levels of NDMA or NDEA may increase cancer risk, but the estimated individual risk from short-term use is low.
Can I get compensation for taking recalled valsartan?
If you developed cancer after long-term use of recalled valsartan, you may be eligible to join a class-action or MDL lawsuit. Contact a licensed attorney specializing in pharmaceutical cases.
Stay Informed and Act Safely
The Valsartan recall was one of the largest in recent pharmaceutical history, highlighting the importance of global quality control in drug manufacturing. While contamination with NDMA and NDEA understandably caused concern, the immediate health risk remains low for most patients.
What’s most important is continuing your treatment safely under medical supervision. Check your prescription’s manufacturer, verify lot numbers against the recall database, and consult your doctor before making any changes.
By staying informed and proactive, you can protect both your heart health and your long-term wellbeing.
✅ Key Takeaways
- Valsartan recall started in 2018 due to nitrosamine contamination (NDMA/NDEA).
- Millions of bottles were recalled worldwide.
- Check your lot number through the FDA recall list.
- Don’t stop medication abruptly—consult your doctor first.
- Legal cases and settlements remain active as of 2025.
- Uncontaminated valsartan and alternatives remain safe and effective for blood pressure control.
Disclaimer
This article is provided for informational and educational purposes only and does not constitute medical or legal advice. Readers should not interpret this content as a substitute for consultation with a qualified healthcare provider or attorney.
Always speak with your doctor or pharmacist before stopping, changing, or starting any medication. Information about the Valsartan recall, contamination risks, and ongoing lawsuits may change over time — please verify the latest updates through official regulatory sources such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or your local health authority.
If you believe you have experienced health issues related to recalled medication, consult your healthcare provider immediately and, if necessary, seek legal guidance from a licensed attorney.
The publisher assumes no responsibility or liability for any errors, omissions, or actions taken based on the information provided.