Sandoz Inc. voluntarily recalls Losartan Potassium and Ezetimibe in prescription drug bottles in the U.S. due to failure to meet child-resistant closure requirements
Aug 29, 2019
Voluntary recall and notice of corrective action issued because the cap and bottle combination for two medicines distributed in capped bottles in the U.S. does not meet U.S. child-resistant packaging requirements
Particular lots of Ezetimibe 10mg Tablets and Losartan Potassium 50 mg Tablets packaged in prescription drug bottles are recalled
There are no quality or safety issues with the medicines for their intended use. Patients should immediately secure bottled medicines and their contents to keep out of the sight and reach of children
Patients should continue to use the medicine as prescribed and call 1-800-525-8747 option # to receive free replacement child-resistant bottle caps.
Princeton, New Jersey, August 29, 2019 – Sandoz Inc., a division of Novartis, today announced a voluntary recall and corrective action notice for particular lots of product distributed in the U.S. in prescription drug bottles because the cap and bottle combination does not meet federal standards for child-resistant packaging, posing a risk of harm if the tablets are swallowed by children.
At Sandoz, we take our responsibility for consumer safety very seriously. As soon as we became aware of the issue, we immediately notified the U.S. Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) that the cap and bottle combination at issue is not compliant for consumer home use. As a result, we are voluntarily recalling and implementing corrective action for these selected lots.
This action is only necessary because the cap and bottle combination does not meet federal standards for child-resistant packaging. There are no quality or safety issues with the medicines for their intended use. Patients should continue taking their medicine as directed by their physician, secure the bottled medicines so that they are out of the sight and reach of children, and contact Sandoz at 1-800-525-8747 option # or www.us.sandoz.com for more information and free replacement child-resistant bottle caps.
The products affected by the recall and corrective action notice include production lots of the following medicines that have been distributed by Sandoz in the U.S. to date:
Ezetimibe: 10mg tablets in 30 and 90 count bottles. The only affected National Drug Code (NDC) numbers are # 0781-5690-31 (30 tablets) and # 0781-5690-92 (90 tablets).
Losartan Potassium: 50mg in 30 count bottles. The affected NDC number is # 0781-5701-31.
Consumers or pharmacies who have impacted prescription drug bottles with these NDC numbers in their homes or pharmacies should contact Sandoz at 1-800-525-8747 option # for free replacement child-resistant bottle caps. A complete list of the affected lot numbers with expiry dates and package photos is available at
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.