Coronavirus (COVID-19) Update: We are fully operational and remote, we are available over the phone 8am-5pm Monday-Friday, available over email and able to provide services to our existing and future clients. More FAQs »

Mon-Fri 8AM-5PM
English or Spanish


Expanding List of Recalled Blood Pressure Medications: the Reason Uncovered

Posted on by in Product Liability


It was a perplexing situation when a blood pressure medication was withdrawn from the market after it was discovered that the wrong pills were in the packaged bottle.

This happened in late August 2018 when Accord Healthcare Inc recalled specific batches of 100-pill bottles filled with Spironolactone tablets USP 25 mg, which were supposed to be containing Hydrochlorothiazide USP 12.5 mg blood pressure medication.

Spironolactone treats congestive heart failure and liver cirrhosis.

The officials of the Food and Drug Administration (FDA) said that the effects of intake of incorrect medication could be either limited or life-threatening and depend on the individual. These types of injuries often pose unique challenges, but The Law Offices of Sean M. Cleary can help you.

A few weeks before this incidence, numerous blood pressure medications were found to have unexpected contaminant called N-nitrosodimethylamine (NDMA), a probable carcinogen, because of which the drugs were recalled. The recalled blood pressure medications included Valsartan, Irbesartan, and Losartan. The FDA stated that the presence of NDMA was unexpected and changes in the manufacturing process were speculated as the reason for the impurity.

According to the U.S. Environmental Protection Agency (EPA), NDMA is a by-product of industrial processes and laboratory studies have shown this to be a dangerous chemical. Chronic exposure to high levels of NDMA is likely to cause damage to the liver in humans. Further, FDA has started investigations regarding the amount of NDMA that was present in the recalled medications and the subsequent effects that might have occurred in patients exposed through medications.

Recently, on October 26, 2018, the FDA had announced the recall of 22 batches of Irbesartan by Aurobindo Pharma Limited. Some of the batches of Irbesartan tablets manufactured by ScieGen Pharmaceuticals were impacted too. Sandoz Inc, the generic division of Novartis has voluntarily recalled Losartan tablets earlier this month because it had chances of containing an impurity called N-nitrosodiethylamine (NDEA), which the International Agency for Research on Cancer (IARC) regarded as a probable human carcinogen.

The patients who are currently being treated with this medication will need to consult their physician before discontinuing its use because the risk of stopping the medication abruptly outweighs the possible risk of developing cancer. It is said that the affected batches of Losartan included 100mg/25mg tablets bearing the lot number JB8912 manufactured at by Zhejiang Huahai Pharmaceutical Co. in Linhai, China and was released to the market only after October 8, 2018. The patients should be proactive and ascertain whether their medication has been recalled by looking at the name of the drug and company mentioned in the prescription label.

The drug manufacturing companies need to evaluate their products thoroughly for safety in order to obtain approval from the FDA. In spite of the scrutiny, many drugs get recalled and labeled as dangerous after being released to the market and used by patients. This eventually directs us to the fact that FDA approval solely does not guarantee consumers a safe drug.

People injured by Side Effects of Defective Medications deserve compensation

Sean M. Cleary specializes in product liability litigation and has represented several clients that have suffered serious adverse events due to the intake of medications. At The Law Offices of Sean M. Cleary, the attorneys work with medical experts and develop strong claims in order to secure maximum eligible compensation from the pharmaceutical companies for any injury or side effect resulting from defective medications.

If you or your family member has been a victim of defective medication, both prescription or over the counter drugs, get in touch with our product liability lawyer right away as there are time limits within which a claim has to be filed. We will evaluate your case free of cost and will let you know of compensation and benefits you may receive.


For questions and free legal advice to help individuals please call us

Disclaimer: Please note that the information provided on this site is not formal legal advice, also the site does not allow you to form an attorney-client relationship.