The blood pressure drug Irbesartan was recalled because it may contain a cancer-causing impurity.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Irbesartan induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: Irbesartan Recalled After 4 Illnesses Reported
In October 2021, Lupin Pharmaceuticals Inc. recalled certain batches of Irbesartan and Hydrochlorothiazide tablets after they tested positive for the impurity N-nitrosoirbesartan.
From October 8, 2018 through September 30, 2021, Lupin received 4 reports of illness from Irbesartan. The recall involves all batches of:
- Irbesartan Tablets USP 75mg, 150mg and 300mg
- Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg
Irbesartan Recall Expanded for Cancer-Causing Impurity
In January 2019, a recall was issued for one (1) lot of irbesartan and seven (7) lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA).
For a complete list of irbesartan medications under recall, please click here.
The expanded recall involves the products listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle.
| Product | NDC Code | Lot Number | Expiry Dates | Distribution Date |
|---|---|---|---|---|
| IRBESARTAN TABLETS 300MG 90CT | 43547-376-09 | 331B18009 | 02/2021 | 8/9/2018 |
| IRBESARTAN/HCTZ 300MG/12.5MG 30CT TABLETS |
43547-331-03 | 327A18001 | 03/2021 | 7/10/2018 |
| IRBESARTAN/HCTZ 300MG/12.5MG 30 CT TABLETS |
43547-331-03 | 327A18002 | 03/2021 | 7/10/2018 |
| IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS |
43547-331-09 | 327B18008 | 03/2021 | 7/10/2018 |
| IRBESARTAN/HCTZ 300MG/12.5MG 90CT TABLETS |
43547-331-09 | 327B18009 | 03/2021 | 7/10/2018 |
| IRBESARTAN/HCTZ 150MG/12.5MG 30CT | 43547-330-03 | 325D18004 | 03/2021 | 7/10/2018 |
| IRBESARTAN/HCTZ 150MG/12.5MG 90CT TABLETS |
43547-330-09 | 325B18004 | 03/2021 | 8/24/2018 |
| IRBESARTAN/HCTZ 150MG/12.5MG 30CT TABLETS |
43547-330-03 | 325D18005 | 03/2021 | 7/10/2018 |
What is Irbesartan?
Irbesartan is a generic drug for people with high blood pressure (hypertension), and kidney disease in some patients. It is manufactured and sold by a variety of pharmaceutical companies.
Irbesartan Brand-Names
- Avapro
- Avalide
- Karvea
- Irbesartan (Generic)
What is the Problem?
Irbesartan has been linked to a possible risk of cancer due to a toxic chemical impurity left over from the drug’s manufacturing process. The problem was only discovered recently, but patients may have been at risk of cancer, liver damage, and other side effects for many years.
Irbesartan Recalls
For a complete list of irbesartan medications under recall, please click here.
January 18, 2019 — Prinston Pharmaceutical Inc., doing business as Solco Healthcare LLC., recalled one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets due to the detection of N- nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
October 26, 2018 — Aurobindo Pharma Limited announced a recall for Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA).
October 30, 2018 — SciGen Pharmaceuticals, Inc. announced a recall for Irbesartan Tablets, USP (75-mg, 150-mg, and 300-mg dosage) due to the presence of an impurity, NDEA. The products were labeled as “Westminster Pharmaceuticals” and “Golden State Medical Supply, Inc. [GSMS].”
Blood Pressure Drug Recalls
The FDA also announced similar recalls for Valsartan and Losartan, two other blood pressure drugs that are similar to Irbesartan.
What is NDEA?
N-nitrosodiethylamine (NDEA) is a cancer-causing chemical impurity that is a byproduct of the industrial processes used to make Irbesartan. It is classified as a “probable human carcinogen” by the International Agency for Research on Cancer (IARC).
What Should I Do?
The FDA recommends that people who are taking these medications should talk to their doctor about switching treatments. Never stop taking a prescription drug without talking to your physician first. Doing so could cause serious health consequences, the FDA warned.
Irbesartan Lawsuits
Patients who developed cancer or suffered a severe liver injury may be in a position to file an Irbesartan lawsuit. Our lawyers are experienced in filing pharmaceutical drug injury lawsuits against companies who sell defective drugs, or fail to warn about side effects.
Do I have a Irbesartan Lawsuit?
The Schmidt Firm, PLLC is currently accepting Irbesartan induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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