Sandoz Recalls Losartan and Ezetimibe Bottles for Child-Resistant Closure Failure
Sandoz is recalling approximately 636,000 bottles of Losartan Potassium and Ezetimibe because the caps do not meet child-resistant requirements, posing a poisoning risk to children.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (poisoning risk to children) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Sandoz Inc. is recalling approximately 636,000 bottles of prescription medications Losartan Potassium and Ezetimibe. The recall involves specific lot numbers of Ezetimibe 10mg tablets (30 and 90 count bottles) and Losartan Potassium 50mg tablets (30 count bottles). The bottles were distributed to clinics and pharmacies nationwide from July 2018 through August 2019.
The recall was issued because the prescription drug packaging is not child-resistant as required by the Poison Prevention Packaging Act. This defect poses a poisoning risk if the medication is swallowed by children. No injuries have been reported in connection with this recall.
Consumers should immediately secure the medications to keep them out of the sight and reach of children. Once the medication is secured, consumers can continue to use it as directed. Consumers should contact Sandoz at 800-525-8747 or visit www.us.sandoz.com to request a free replacement child-resistant bottle cap.
The recalled product
- Product
- Losartan Potassium and Ezetimibe prescription drug bottles
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 636,000
Distribution
Distributed nationwide across the United States.
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