FDA Recalls Montelukast Sodium Tablets, Used To Treat Asthma

The U.S. Food and Drug Administration has announced a voluntary recall of one lot of Montelukast Sodium Tablets, which is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma.

The recalled bottles have the following lot numbers: MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

"Losartan is often used alone or in combination with other medications to treat high blood pressure," the FDA wrote in its press release. "Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart)."

Patients who have the recalled bottles should contact their health care provider or pharmacist immediately, the FDA said.

"This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure," the FDA wrote in its press release. "This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately."

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

Along with the treatment of asthma, Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise and to treat the symptoms of seasonal and perennial allergic rhinits.

Read the full statement from the FDA here.