FDA Expands Recalls of Common Blood Pressure and Heart Medications Over Cancer Concerns

The U.S. Food and Drug Administration (FDA) has expanded its voluntary recall of several medications used to treat high blood pressure and heart failure over concerns that an active ingredient in the drugs could be contaminated with a cancer-causing agent.

The agency reported that traces of N-nitrosodimethylamine (NDMA), a “probable human carcinogen,” was found in the active ingredient valsartan in the recalled products. The FDA noted not all products containing valsartan are contaminated and being recalled. A third-party supplied the valsartan contained in the recall.

The FDA updated the list of products (SEE BELOW) included in the recall and the list of those unaffected.

“FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients are not at risk of NDMA formation,” the FDA said. “The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities.”

Patients are urged to look at the drug name and company name on the label of their prescription bottle to determine whether a specific product has been recalled. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine to find out the company name.

If a patient is taking one of the recalled medicines, they should follow the recall instructions each specific company provided, which will be available on the FDA’s website.

If a patient’s medicine is included in the recall, they should contact their health care professional to discuss their treatment options, which may include another valsartan product this recall doesn’t affect or an alternative option.

The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

“The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company,” the FDA said in a news release.

The presence of NDMA is “thought to be related to changes in the way the active substance was manufactured,” the agency said.

Updated list of affected manufacturers/products: 

• Valsartan – Prinston – Pharmaceutical Inc.
• Valsartan – AvKARE
• Valsartan – A-S Medication Solutions LLC
• Valsartan – Bryant Ranch Prepack, Inc.
• Valsartan – HJ Harkins Company
• Valsartan – Major Pharmaceuticals
• Valsartan – Solco Healthcare
• Valsartan – Northwind Pharmaceuticals
• Valsartan – Teva Pharmaceuticals Industries Ltd.
• Valsartan/Hydrochlorothiazide (HCTZ) – Proficient Rx LP
• Valsartan/Hydrochlorothiazide (HCTZ) – Remedy Repack
• Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
• Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Injustries Ltd.

For more information on this recall, click here.

The FDA has also compiled an updated list of medications not included in the recall:

• Amlodipine and Valsartan – Alembic Pharmaceuticals Limited
• Valsartan/Hydrochlorothiazide (HCTZ) – Alembic Pharmaceuticals Limited
• Valsartan – Alembic Pharmaceuticals Limited
• Byvalson (Nebivolol and Valsartan – Allergan, Inc.
• Valsartan – American Health Packaging
• Valsartan – Amneal Pharmaceuticals LLC
• Diovan and Valsartan  – Aphena Pharma Solutions
• Valsartan/Hydrochlorothiazide (HCTZ) – Apotex Corp.
• Amlodipine and Valsartan – Aurodindo Pharma Limited
• Valsartan  – AcPAK
• Valsartan – Cardinal Health
• Diovan – Carilion Materials Management
• Amlodipine and Valsartan – Gavis Pharmaceuticals, LLC
• Valsartan  – Jubilant Cadista Pharmaceuticals Inc.
• Valsartan – Lucid Pharma
• Amlodipine and Valsartan – Lupin
• Valsartan – Macleods Pharmaceuticals USA
• Amlodipine and Valsartan – Mylan
• Valsartan/Hydrochlorothiazide (HCTZ) – Northwind Pharmaceuticals
• Diovan  – Novartis Pharmaceuticals Corp.
• Amlodipine and Valsartan – Novel Laboratories, Inc.
• Valsartan  – Ohm Laboratories, Inc.

For more information on various medications that are not included in the recall, click here.