The Lupin Blood Pressure Medication Recall: What To Know

The October 2021 recall affected two medications.

On occasion, the U.S. Food and Drug Administration (FDA) may find that medical products are problematic for individuals and their health. In October 2021, the FDA announced a recall of several batches of a blood pressure medication over concerns that it could have contained high levels of a cancer-causing impurity. Learn more about the recall, what a recall means, and what to do if a recall affects the medications you take.

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What Medication Was Recalled?

Lupin Pharmaceuticals voluntarily recalled several batches of two drugs: Irbesartan tablets as well as its Irbesartan and Hydrochlorothiazide tablets.

Irbesartan tablet USP is designed to treat high blood pressure, lower blood pressure, and treat diabetic nephropathy in patients with high blood pressure who also have type 2 diabetes. Irbesartan and Hydrochlorothiazide tablet USP is a combination of irbesartan and hydrochlorothiazide, a type of diuretic that's used for high blood pressure in patients who need more than one medication to control their blood pressure.

"The problem is the Irbesartan component," said Jamie Alan, PharmD, associate professor of pharmacology and toxicology at Michigan State University. Irbesartan works by blocking a compound in the body called angiotensin, which raises blood pressure, Alan explained.

What Happened Regarding the Recall?

An analysis found that certain batches of both medications had exceeded safe levels of the impurity N-nitrosoirbesartan, which is a probable human carcinogen—meaning it had the possibility of causing cancer. Following the analysis, the recall came about after the company received reports of people becoming ill when taking the medication.

Between October 8, 2018, and September 30, 2021, Lupin received notification about four cases of illness from Irbesartan, though no reports of people becoming sick from Irbesartan and Hydrochlorothiazide were received. It's not clear if the cases involved people who developed cancer or another illness.

The FDA said that "out of an abundance of caution," the company would be recalling all batches of Irbesartan tablets USP 75mg, 150mg, and 300mg, and Irbesartan and Hydrochlorothiazide tablets USP 150mg/12.5mg and 300mg/12.5mg. The FDA also provided a full list of the recalled lots.

What Does It Mean When Medications Are Recalled?

According to the Food and Drug Administration (FDA), the primary purpose of a drug recall is to protect the public from products that may be harmful or defective. Of note, the FDA is unable to authorize the withdrawal of medications from the market; they can only request that the company that offers the product recall it.

A drug recall may fall under one of three categories:

  • Class I: Designated for products that may lead to serious health issues or death
  • Class II: Designated for products that may lead to temporary health issues or a slight, serious threat
  • Class III: Designated for products that violate FDA laws related to labels or manufacturing but are unlikely to cause health issues

Additionally, the FDA does not announce all recalls to the public: It prioritizes notifying the public about recalls "when a product that has been widely distributed or poses a serious health hazard is recalled." The FDA also posts recalls on a weekly basis and will determine how effective a recall is based on how well a company communicates to consumers about the recalled product and its removal from the market.

What To Do if Your Medication Has Been Recalled

If you find out that your medication is under recall, the FDA says to speak with your healthcare provider about how to proceed. When medications fall under a Class I recall, the notifications include specific instructions for patients detailing what to do—and they should be followed accordingly. Additionally, you'll want to return any unused medicine to your pharmacist when your healthcare provider has prescribed you an alternative medication to the recalled one.

Concerning the October 2021 blood pressure medication recall, the FDA recommended that patients not stop their use of the medicines. "Patients taking, Irbesartan Tablets USP, 75mg, 150mg, and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment," the FDA stated.

Alan explained that you don't want to suddenly go off blood pressure medication if you need it. "If you stop taking the medication, your blood pressure could go up, raising your risk of stroke and other bad consequences," Alan said.

Just make sure you contact your healthcare provider as soon as possible. They can offer guidance that may involve switching you to a different blood pressure medication that functions the same way, Alan added.

As for the N-nitrosoirbesartan impurity, Alan urged people not to panic. "The overall risk is fairly low, and cancer is a very complex disease," Alan explained. "The risk of cancer is complicated by many things including genetics, environment, diet, and more. I would not panic, but I would call your doctor."

A Quick Review

Unfortunately, medication recalls happen, but don't panic. If your medication is recalled, like the blood pressure medication, Irbesartan, was in 2021, contact your healthcare provider regarding what to do. They may advise you to stop your medication, keep taking it until you receive a new one, or switch to a new medication.

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  1. US Food & Drug Administration. Lupin Pharmaceuticals, Inc. Issues voluntarily nationwide recall of all Irbesartan tablets and Irbesartan and hydrochlorothiazide tablets due to potential presence of N-nitrosoirbesartan impurity.

  2. US Food & Drug Administration. Drug recalls.

  3. National Library of Medicine. Food and drug administration recalls.

  4. US Food and Drug Administration. FDA's role in drug recalls.

  5. US Food & Drug Administration. Recalls of angiotensin II receptor blockers (ARBs) including Valsartan, Losartan, and Irbesartan.

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