Valsartan Recall: FDA Issues Warning to API Manufacturer


The manufacturer of the active pharmaceutical ingredient found in the medication has received a letter from the agency.

The FDA has issued a warning letter to the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of the agency’s continuing investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines.

The letter to Zhejiang Huahai Pharmaceutical Co Ltd (ZHP), in Linhai, Taizhou Zhejiang, China, outlines several manufacturing violations at the company’s Chuannan facility, including change control, cross contamination from 1 manufacturing process line to another, and impurity control.

The ZHP facility manufactures API including valsartan, a drug in the angiotensin II receptor blocker (ARB) class used to treat heart failure and high blood pressure. The FDA previously put this facility on import alert, which stopped all API made there and finished drug products made using its API from legally entering the United States. The import alert was based, in part, on high levels of impurities found in API manufactured by ZHP.

This week’s warning letter is another step forward in the continuing investigation, according to the FDA.

The agency is still looking into the root cause of the impurity.

“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities. As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products," FDA Commissioner Scott Gottlieb, MD, said in a statement.

"The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk,” he said.

Recalls of products containing valsartan began in July, because of the presence of N-Nitrosodimethylamine (NDMA) in API supplied by ZHP. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA), known animal and suspected human carcinogens.

Certain ARB products and certain products that contain ARBs and 1 or more other active ingredients in a single dosage form have been recalled.

There may be confusion regarding which products are affected by ARB recalls and which are not, according to the FDA.

The agency’s website provides lists of valsartan products not under recall valsartan products under recall, as well as related irbesartan products under recall for health care providers, patients, and pharmacists to accurately confirm which products are affected.


  • Mylan Expands Voluntary Nationwide Recall of Valsartan Tablets
  • New Recall Announced for Products Containing Valsartan
  • Second Impurity Found in Recalled Valsartan Drug Products

The FDA is advising patients taking any recalled ARB to continue taking their medicine until their doctors offer an alternative treatment option or their pharmacists provide a replacement. It also is important to know that not all ARBs contain NDMA or NDEA, so doctors may prescribe a different medication that treats the same condition or pharmacists may be able to provide a refill of medication not affected by the recall.

Health care providers, patients, and pharmacists may contact the FDA’s Division of Drug Information for questions about ARB recalls. Call 855-543-3784, email, or visit the FDA’s ARB recall web page, for more information. A question and answer webpage also provides information about these recalls.


FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications [news release]. Silver Spring, MD; December 11, 2018: FDA website. Accessed December 2018.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U -
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii |
Pharmacy Interior | Image Credit: Tyler Olson -
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi -
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen |
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/ |
Image credit: fidaolga -
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund |
Young male pharmacist giving prescription medications to senior female customer in a pharmacy | Image Credit: Zamrznuti tonovi -
© 2023 MJH Life Sciences

All rights reserved.