Teva Pharmaceuticals Expands Losartan Recall for Cancer-Causing Chemical

Published on June 13, 2019 by Sandy Liebhard

Teva Pharmaceuticals has expanded the generic losartan recall it announced in April, amid concerns that even more tablets could contain a cancer-causing chemical.

Teva Pharmaceuticals Recalls 25, 50, & 100 mg Losartan

The initial recall already included thousands of bottles of Losartan potassium tablets (six lots of 25 mg strength and 29 lots of 100 mg strength). This expansion adds six lots of the 50 mg strength and four more lots of the 100 mg strength described as:

• Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and “>” on the other side.
• Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and “>” on the other side.

According to Teva Pharmaceuticals, testing recently detected levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above 9.82 ppm, the level which the U.S. Food & Drug Administration (FDA) considers acceptable. Over the long-term, exposure to NMBA could increase an individual’s risk for certain cancer.

“Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment,” the FDA said. “The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without alternative treatment.”

Generic ARB Recalls

Teva Pharmaceuticals is just one of numerous generic drug makers that have recalled Angiotensin II Receptor Blockers (ARB) since last summer. The various medications in this class are indicated to treat high blood pressure, congestive heart failure, and nephropathy in Type 2 diabetes patients.

So far, three different potentially carcinogenic nitrosamines – NMBA, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) – were detected in active pharmaceutical ingredients supplied by Hetero Labs of India or China-based Zhejiang Huahai Pharmaceutical Co., Ltd.

In addition to losartan potassium tablets, the recalls have included:

• Single-ingredient valsartan
• Amlodipine in combination with valsartan
• Valsartan HCTZ
• Single-ingredient irbesartan
• Irbesartan HCTZ
• Amlodipine in combination with losartan
• Losartan HCTZ

Consumers should contact their pharmacy to determine if their ARB is included in one of these recalls. They can also check regularly-updated lists of recalled  valsartan products, losartan medications, and irbesartan products  posted on the FDA’s website.

So far, Teva Pharmaceuticals has not received any reports of adverse events related to its losartan recall, but said that “based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.”