Posted from: Friday, August 09, 2019 - 01:39 PM - Present

MacLeods Voluntarily Recalls Losartan Products

June 25, 2019 – MacLeods Pharmaceuticals Limited has announced a voluntary recall of two lots of Losartan Potassium Tablets (50mg) and 30 lots of Losartan Potassium/Hydrochlorothiazide Tablets (50mg/12.5mg, 100mg/25mg, and 100mg/12.5mg). The active pharmaceutical ingredient (API) losartan in these products has been found to contain trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the U.S. FDA’s interim acceptable exposure limit of 9.82 ppm.

NMBA is considered a potential human carcinogen (cancer-causing agent). However, patients should not stop taking their medication without first reaching out to their pharmacist or healthcare provider for a replacement product or advice on switching to an alternative treatment. The risk of harm from stopping the medication may outweigh the risk of harm presented by exposure to NMBA. As of the date of the recall, MacLeods had not received any reports of adverse events related to the recalled products.

For help with medication questions related to the recall, or to report an adverse event, consumers can contact MacLeods Pharmaceuticals Limited at 855-926-3384. Adverse events can also be reported to the FDA’s MedWatch program, and should be reported to the patient’s healthcare provider. General questions regarding the return of the recalled products should be directed to Qualanex at 888-280-2046 or

Additional details regarding the recall, including how to identify the recalled products, can be found at the FDA’s website.

Benecard Central Fill dispensed a small number of the recalled product and has contacted the affected members.

Last Updated Wednesday, October 23, 2019 - 07:37 PM.