Drug recall notice for irbesartan tablets

To assist you in the care of your patients, we would like to alert you to the recall of all batches of irbesartan 75 mg, 150 mg and 300 mg tablets and irbesartan and hydrochlorothiazide 150 mg/12.5 mg and 300 mg/12.5 mg tablets on Oct. 14, 2021.¹ We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Lupin Pharmaceuticals, Inc., is voluntarily recalling these products after an analysis revealed that certain tested batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. N-nitrosoirbesartan impurity is a probable human carcinogen based on results from laboratory tests.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

To date, Lupin Pharmaceuticals has received no reports of illness that appear related to this issue.

Medications included in this recall

Visit the FDA website for specific details about the recalled medication.

Recommendations

Other lot numbers for these products are unaffected and remain available.

Information for providers:¹

• Healthcare providers with questions can contact Inmar Rx Solutions, Inc. at 855-769-3988 or 855-769-3989, Monday – Friday, 9 a.m. – 5 p.m., Eastern time.
• Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • Online: Complete and submit the report.
    • Select “Consumer/Patient (FDA Form 3500B).”
  • Regular mail or fax: Download the form.
    • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).