Valsartan Manufacturers and Distributors

At this time, there are dozens of valsartan manufacturers and distributors in the United States. Novartis originally manufactured valsartan blood pressure medication under the brand name Diovan. The U.S. Food and Drug Administration first approved Diovan in 1996. The drug generated $5.7 billion worldwide in 2011.

After the patent expired in 2012, several generic manufacturers began making and distributing valsartan.

In June 2018, Zhejiang Huahai Pharmaceutical Co. Ltd. and its Prinston Pharmaceuticals subsidiary informed the FDA that it had discovered N-nitrosodimethylamine (NDMA) — a known carcinogen — in its valsartan. In July 2018, the FDA announced a valsartan recall.

After the recall, people began filing valsartan lawsuits. Drugwatch’s legal partners are currently accepting cases for valsartan NDMA cancer.

As of 2022, several distributors who receive their valsartan from Zhejiang Huahai and other manufacturers including Hetero Labs, Mylan and Aurobindo have recalled products.

Zhejiang Huahai Pharmaceutical Co. Ltd. is a Chinese pharmaceutical company headquartered in Linhai City, China, and was founded in 1989. It manufactures the active ingredients for many medications including generic blood pressure medications, antidepressants, diabetes and HIV medications.

Zhejiang Huahai has been reported to be the largest supplier of “pril products” in the world. Americans know pril products as blood pressure drugs in the angiotensin-converting enzyme (ACE) inhibitor class. These include lisinopril, captopril and enalapril, among others.

Zhejiang Huahai also owns Huahai U.S. Inc., Prinston Pharmaceuticals and Solco Healthcare.

Huahai US Inc.

Huahai US Inc. is Zhejiang Huahai’s American division, headquartered in Cranbury, New Jersey. The parent company founded Huahai US in 2004. In 2010, it began developing and marketing generic drugs through Prinston Pharmaceutical.

In August 2018, the company released a statement on behalf of its parent company about the valsartan recall. It disputes the speculation that NDMA may have been in the company’s valsartan since at least 2016. In fact, the FDA did not find any impurities in Zhejiang Huahai’s valsartan in previous inspections in January 2017 and September 2017, according to the statement. Inspectors did not find the NDMA impurity until June 2018.

The company said it was committed to working with regulatory agencies through the valsartan recall.

“To protect human health, recalls at the consumer level are being undertaken by the Company and its affiliates, and these will continue under the close supervision of the FDA and regulatory agencies in all affected countries,” Huahai US said in its statement.

Prinston Pharmaceutical

Prinston Pharmaceutical is a subsidiary of Zhejiang Huahai located in Somerset, New Jersey. It manufactured its first drug in 2010.

In addition to valsartan, it manufactures and develops the active ingredients in generic versions of several drugs, such as Lotensin, Wellbutrin SR, Lexapro, Zestril, Paxil, Risperdal. It also distributes drugs manufactured by Huahai US and Zhejiang Huahai through Solco Healthcare.

Recalled Valsartan Lots Distributed by Prinston Pharmaceutical and Solco Healthcare*

• Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
• Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Novartis manufactures brand-name drugs with valsartan as the active ingredient. Their brand name valsartan products are Diovan, Diovan HCT, Entresto, Exforge and Exforge HCT. None of these products are included in the valsartan recall.

In addition to Zhejiang Huahai, other manufacturers supplied distributors with tainted valsartan.

Hetero Labs

Hetero Labs is an Indian pharmaceutical company that manufactures active ingredients for several generic drugs, including valsartan. It is the world’s largest producer of anti-retroviral drugs that treat HIV and AIDS. Camber Pharmaceuticals distributed Hetero’s valsartan products in the United States.

The FDA added products containing valsartan manufactured by Hetero in August 2018. The amount of NDMA found in Hetero’s products is less than that found in Zhejiang Huahai’s, but the company uses a similar manufacturing process.

Recalled Valsartan Manufactured by Hetero Labs and Distributed by Camber Pharmaceuticals Inc.*

• Valsartan Tablets, 40mg, 80mg, 160mg, 320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Mylan

Mylan is one of the largest global manufacturers of active pharmaceutical ingredients. They have more than 7500 products including over-the-counter as well as brand and generic prescription pharmaceuticals.

The FDA added products containing valsartan manufactured by Mylan in November 2018 due to the presence of N-nitrosodiethylamine (NDEA), an impurity related to NDMA.

Recalled Valsartan Manufactured by Mylan Pharmaceuticals Inc.*

• Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
• Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
• Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Aurobindo Pharma

Aurobindo Pharma is an Indian pharmaceutical company exporting to over 150 countries. It is the market leader in semi-synthetic penicillin and has a number of other products in therapeutic areas such as gastroenterology, cardiology and neurology, as well as other antibiotics, antidiabetes and antiretroviral drugs.

The FDA added products containing valsartan manufactured by Aurobindo in January 2019 due to the presence of NDEA.

Recalled Valsartan Manufactured by Aurobindo Pharma Inc.*

• Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
• Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
• Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Aside from Solco Healthcare, other large U.S. distributors include Major Pharmaceuticals, Teva Pharmaceutical Industries and Torrent. All three companies received tainted valsartan from Zhejiang Huahai.

Major Pharmaceuticals

Major Pharmaceuticals is a large U.S. valsartan distributor founded in 1982. The company’s headquarters is located in Livonia, Michigan. It received its tainted valsartan through Teva Pharmaceuticals.

Recalled Valsartan Distributed by Major Pharmaceuticals*

• Valsartan 80mg and 160mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Teva Pharmaceuticals

Teva Pharmaceuticals is the largest producer and distributor of generic medication worldwide. The company is headquartered in Petach Tikva, Israel. Its U.S. headquarters, Teva North America, is located in North Wales, Pennsylvania.

It received its valsartan supply from Zhejiang Huahai. Teva said that it had not received any reports of adverse events related to the valsartan recall. These products went to several wholesalers, distributors, pharmacies and repackagers.

Recalled Valsartan Distributed by Teva Pharmaceuticals*

• Valsartan Tablets, 40mg, 80mg, 160mg, 320mg
• Valsartan/HCTZ 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
• Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg
• Amlodipine/Valsartan/HCTZ 5mg/160mg/12.5mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

Torrent Pharmaceuticals Ltd.

Torrent Pharmaceuticals Limited is an Indian company based in Gujarat, India. It manufactures and distributes generic medications. It acquired its tainted valsartan ingredients from Zhejiang Huahai.

Recalled Valsartan Distributed by Torrent Pharmaceuticals*

• Valsartan Tablets, 80mg, 160mg, 320mg
• Amlodipine/Valsartan/HCTZ 5mg/160mg/12.5mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, 10mg/320mg/25mg
• Amlodipine/Valsartan 5mg/160mg, 10mg/160mg, 5mg/320mg, 10mg/320mg

*Please visit the FDA website or speak to your pharmacist for information about specific lot numbers, expiration dates and NDC codes.

The FDA has identified valsartan products that do not contain nitrosamine contaminants. There are also many products that have not yet been tested.

*see FDA website for specific products from these companies