Montelukast Sodium Tablet Recall Issued Due to Incorrect Drug In Bottles

Federal health officials have announced a recall for specific lots of sodium tablets, after finding that sealed bottles actually contained potassium tablets, posing an increased risk of blood pressure complications and renal dysfunction for individuals who take the wrong medication. 

The Montelukast Sodium Tablet recall was announced by the FDA on August 31, after it was discovered that Losartan Potassium Tablets may actually be inside of the sealed bottles.

The sodium tablets are designed to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma, and are used to prevent breathing difficulties during exercise and seasonal allergies. It is part of a drug class called leukotriene receptor antagonists, which prohibit symptoms of asthma and allergies.

According to the recall, the FDA has become aware that at least one lot of Montelukast Sodium Tablets were found to contain Losartan Potassium Tablets, which are used either alone or in combination with other medications to treat high blood pressure and to decrease the risk of stroke in patients with heart conditions.

The tablet mix-up poses an increased risk of renal dysfunction, elevated potassium levels, and low blood pressure. In severe cases, pregnant women accidently taking the blood pressure medication Losartan could put the fetus at serious risk of harm or death.

The recall includes bottles of 10 mg Montelukast Sodium Tablets containing 30 tablets with Lot number MON 17384, NDC number 31722-726-30 and have expiration date of December 31, 2019. The medications were manufactured by Camber Pharmaceuticals Inc., of Piscataway, New Jersey and were distributed to pharmacies and hospitals across the United States.

Patients with prescribed Montelukast Sodium Tablets should check the pills to ensure they are the correct prescription. Montelukast sodium tablets are beige, rounded square-shaped film coated tablets with “I” on one side and “114” on the other side. Losartan tablets are white and oval-shaped with the letter “I” printed on one side and the number “5” printed on the reverse.

Patients with the prescribed Montelukast medication should contact their healthcare provider or pharmacist to determine if their medicine is included in the recall. Those unsure of their prescription should check the drug name and company name of the label of the prescription bottle.

For further questions or concerns regarding the recall, patients are encouraged to contact the FDA at 888-INFO-FDA and to report any adverse health events to the FDA’s MedWatch Adverse Event Reporting program.