Danielle Toth  |  October 19, 2021

Category: Legal News

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blood pressure, lupin, and ibersartan
(Photo Credit: Food and Drug Administration)

Lupin Irbesartan, Irbesartan/HCTZ Tablets Recall Overview: 

  • Who: Lupin Pharmaceuticals is recalling several batches of Irbesartan and Irbesartan and hydrochlorothiazide (HCTZ) tablets.
  • Why: Analysis revealed certain tested batches were above the specification limit for the impurity N-nitrosoirbesartan, a probable human carcinogen.
  • Where: The recall is nationwide.

Blood pressure medications have been recalled by Lupin Pharmaceuticals Inc. The drug company is voluntarily recalling several batches of its blood pressure drugs Irbesartan and Irbesartan and hydrochlorothiazide (HCTZ) tablets, according to the Food and Drug Administration (FDA). 

Irbesartan tablet USP is an angiotensin II receptor blocker used to treat hypertension, diabetic nephropathy in hypertensive patients with type 2 diabetes, elevated creatinine levels and proteinuria.

A company analysis revealed that certain tested active pharmaceutical ingredient batches (but not finished product batches) were above the specification limit for the impurity N-nitrosoirbesartan. N-nitrosoirbesartan impurity is a probable human carcinogen, according to the FDA

The recall includes all batches of Irbesartan tablets USP 75 mg, 150 mg and 300 mg and Irbesartan/HCTZ tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg in the United States. The lot numbers of the recalled blood pressure drugs include; H000843, H805727, H901579, H000844, H000964, H804311, H805267, H805268, H805269, H805725, H805726, H901497, H901577, H901578, H902258, H804403, H805251, H805640, H901580, H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, H902140, H804310, H900050, H902262, H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062, H900445, H901489, H901490, H901491, H902261, H804537, H805148, H900063, H900522, H901582, H000963, H804507, H804536, H805070, H805149, H900064, H900523, H901583, H902530, H804192, H805348, H900065, H902264, H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531, and H902532.

From Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to Sept. 30, 2021, Lupin received 4 reports of illness from Irbesartan, according to the FDA.

Blood Pressure Medication Recall Affects Multiple Batches

Patients taking Irbesartan tablets USP 75 mg, 150 mg and 300 mg and Irbesartan and hydrochlorothiazide tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg should continue taking their medication and contact their pharmacist, physician or medical provider for advice regarding an alternative treatment, says the FDA. 

Wholesalers, distributors and retailers that have the recalled tablets should discontinue distribution of the recalled product lots immediately and return them to the distributor, states the blood pressure recall notice. 

Consumers, wholesalers, distributors and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Top Class Actions will continue to monitor this and other drug recalls to help keep the public informed. 

Have you purchased or taken the affected blood pressure tablets? Let us know in the comments!


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105 thoughts onBlood Pressure Drug Recall: Lupin Recalls Tablets After Discovering Human Carcinogen

  1. Ollie wagers says:

    Took blood pressure medicine for years lesparian

    1. Ollie wagers says:

      Took lupin for years for blood pressure been sick for years

  2. ERICA ELKERSON says:

    Added me too

  3. Conrad Baptiste says:

    Please add me

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