Irbesartan and Irbesartan with Hydrochlorothiazide (HCTZ) – Specific lots from Lupin Pharmaceuticals

Updated: 10/20/21

Lupin Pharmaceuticals Inc. is voluntarily recalling certain lots of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.

Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling certain batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure.

What is being recalled?

• Irbesartan and Irbesartan HCTZ manufactured by Lupin Pharmaceuticals. Only specific lot numbers are being recalled.
• You can find general information regarding this recall, including impacted lot numbers, on the FDA website:
  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan

What do I need to know?

• Express Scripts HAS already reached out to all patients impacted by this recall.
• If you have a prescription for an Irbesartan-containing drug product and the manufacture is NOT Lupin, you are not impacted by this recall
• If you have not received a call from Express Scripts Pharmacy regarding this recall, your Irbesartan-containing drug product is not impacted by this recall.
• If you received your Irbesartan-containing drug product from another pharmacy, please contact them for additional information OR you can review the FDA link above for return instructions.
• The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
  • If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
  • Since not all Irbesartan-containing drug product has been recalled, if you need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

You can also report adverse events or quality problems related to the use of the drug to the FDA’s MedWatch Adverse Events Reporting Program. Call 800.FDA.1088 or go to https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program