In a recent safety announcement the U.S. Food and Drug Administration (FDA) alerted American consumers to a recall of two generic blood pressure medications manufactured by Lupin Pharmaceuticals, Inc.: irbesartan tablets and irbesartan and hydrochlorothiazide (HCTZ) tablets.
Classified as an angiotensin II receptor blocker (“ARB,” for short), irbesartan is a type of blood-pressure medication that treats hypertension. ARBs are intended to lower blood pressure and relieve diabetic nephropathy in patients with type 2 diabetes. According to the Mayo Clinic, more than 60 million Americans take an ARB every single day.
Lupin announced its voluntary recall in partnership with the FDA after analysis determined higher-than-specification levels of a carcinogenic impurity in the makeup of the two medications.
The impurity identified in certain batches of irbersartan tablets and irbersartan and hydrochlorothiazide (HCTZ) tablets is N-nitrosoirbesartan, which, according to the FDA, is classified as a “probable carcinogen,” meaning the impurity could cause the development of cancer.
The recall follows on the heels of reports that at least four individuals became ill after taking ibersartan tablets. These adverse reactions were reported between Oct. 8, 2018 and Sept. 30 2021. To date, the FDA has not received any adverse reports concerning irbesartan and HCTZ tablets.
Lupin discontinued the marketing of irbesartan and irbesartan and HCTZ tablets in January 2021.
Which Medications Are Being Recalled?
According to the FDA, certain lots of Irbesartan tablets and irbesartan and HCTZ tablets are being recalled “out of an abundance of caution.”
The specific medications and dosages impacted by the recall include:
- Irbesartan tablets USP 75mg, 150mg, 300mg
- Irbesartan and HCTZ tablets USP 150mg/12.5mg and 300mg/12.5mg
The product lots being recalled are as follows:
|Product||Product Lot Numbers|
|Irbesartan Tablets USP, 75mg||H000843, H805727, H901579, H000844, H000964, H804311, H805267, H805268, H805269, H805725, H805726, H901497, H901577, H901578, H902258|
|Irbesartan Tablets USP, 150mg||H804403, H805251, H805640, H901580, H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, H902140|
|Irbesartan Tablets USP, 300mg||H804310, H900050, H902262, H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062,
H900445, H901489, H901490, H901491, H902261
|Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg||H804537, H805148, H900063, H900522,
H901582, H000963, H804507, H804536, H805070, H805149, H900064, H900523, H901583, H902530
|Irbesartan and Hydrochlorothiazide Tablets USP, 300mg/12.5mg||H804192, H805348, H900065, H902264,
H804082, H804121, H804338, H804538,
H804539, H805349, H805350, H900066,
H900067, H902265, H902275, H902276,
Reporting Adverse Reactions to Irbesartan
Patients who are currently taking irbesartan should not stop taking their medications without first discussing the matter with their health care provider(s).
As stated by the FDA,
“Patients taking Irbesartan tablets and Irbesartan and HCTZ tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.”
In the meantime, Lupin Pharmaceuticals is contacting wholesalers, distributors, drug chains, mail-order pharmacies, and supermarkets to arrange for the collection and return of all of the recalled product lots.
The FDA requests that any adverse reactions or concerns about the quality of their medications be reported to the agency’s MedWatch Adverse Event Reporting Program.
To report an adverse event, use one of the following two methods:
- Use the FDA’s online reporting system
- Download the FDA’s form and mail or fax the report to the FDA using the address/telephone number provided on the form
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