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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskCPSC
Medications & Supplements/Prescription Drugs

Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements

Agency Publication Date: August 29, 2019
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Summary

Sandoz is recalling approximately 636,000 bottles of Losartan Potassium and Ezetimibe prescription medications because the packaging is not child-resistant. This recall affects Ezetimibe 10mg tablets (30 and 90-count bottles) and Losartan Potassium 50mg tablets (30-count bottles) sold at clinics and pharmacies nationwide from July 2018 through August 2019. Consumers should immediately secure these medications away from children and contact Sandoz for a free replacement child-resistant cap. While waiting for the replacement cap, the medication can continue to be used as directed provided it is kept in a secure location.

Risk

The drug packaging fails to meet the requirements of the Poison Prevention Packaging Act, creating a risk of accidental poisoning if children are able to open the bottles and swallow the medication. No injuries have been reported to date.

What You Should Do

  1. Check your medication bottles for the following identifying numbers: Ezetimibe 10mg (30-count) with NDC 0781-5690-31; Ezetimibe 10mg (90-count) with NDC 0781-5690-92; or Losartan Potassium 50mg (30-count) with NDC 0781-5701-31.
  2. Verify the lot numbers and expiration dates on the side of the bottle label. Affected Ezetimibe lots include JE4491, JE4492, JE4493, JE4495, JG0308, JG0310, JG0311, JG0312, JG5061, JG5063, JK8921, JK8922, JK8923, JK8924, JL5535, JM2253, JM2254, JM2255, JM2257, JM2258, JM2259, JM5986, JM5987 (all Exp. Aug or Sep 2020), JE4481 (Exp. Aug 2020), JG0249 (Exp. Sep 2020), JK8989 (Exp. Oct 2020), and JN0764 (Exp. Jan 2021). Affected Losartan Potassium lot is HV9471 (Exp. Feb 2020).
  3. Immediately move these medications to a secure location that is out of the sight and reach of children.
  4. Contact Sandoz at 800-525-8747 from 8:30 a.m. to 5 p.m. ET Monday through Friday, or online at www.us.sandoz.com (click on 'Patients and Customers' then 'Product Safety Notices') to receive a free replacement child-resistant bottle cap.
  5. Once the medication is secured, you may continue to use it as directed by your healthcare provider.
  6. Call the CPSC Hotline at 800-638-2772 for additional questions regarding this recall.

Your Remedy Options

📋Replace

Consumers should immediately secure the medications to keep them out of the sight and reach of children and contact Sandoz for a free replacement child resistant bottle cap. Once the medication is secured, consumers can continue to use the medication as directed.

Contact: Sandoz at 800-525-8747 from 8:30 a.m. to 5 p.m. ET Monday to Friday or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices.”

Affected Products

Product: Ezetimibe 10mg Tablets (30-count bottle)
Model:
NDC 0781-5690-31
Lot Numbers:
JE4491 (Exp Aug-2020)
JE4492 (Exp Aug-2020)
JE4493 (Exp Aug-2020)
JE4495 (Exp Aug-2020)
JG0308 (Exp Sep-2020)
JG0310 (Exp Sep-2020)
JG0311 (Exp Sep-2020)
JG0312 (Exp Sep-2020)
JG5061 (Exp Sep-2020)
JG5063 (Exp Sep-2020)
JK8921 (Exp Oct-2020)
JK8922 (Exp Oct-2020)
JK8923 (Exp Oct-2020)
JK8924 (Exp Oct-2020)
JL5535 (Exp Oct-2020)
JM2253 (Exp Oct-2020)
JM2254 (Exp Oct-2020)
JM2255 (Exp Oct-2020)
JM2257 (Exp Oct-2020)
JM2258 (Exp Oct-2020)
JM2259 (Exp Oct-2020)
JM5986 (Exp Oct-2020)
JM5987 (Exp Oct-2020)
Date Ranges: August 2020, September 2020, October 2020
Product: Ezetimibe 10mg Tablets (90-count bottle)
Model:
NDC 0781-5690-92
Lot Numbers:
JE4481 (Exp Aug-2020)
JG0249 (Exp Sep-2020)
JK8989 (Exp Oct-2020)
JN0764 (Exp Jan-2021)
Date Ranges: August 2020, September 2020, October 2020, January 2021
Product: Losartan Potassium 50mg Tablets (30-count bottle)
Model:
NDC 0781-5701-31
Lot Numbers:
HV9471 (Exp Feb-2020)
Date Ranges: February 2020

Product Images

Ezetimibe 10mg Tablets 30 count bottle

Ezetimibe 10mg Tablets 30 count bottle

Ezetimibe 10mg Tablets 90 count bottle

Ezetimibe 10mg Tablets 90 count bottle

Losartan Potassium 50mg Tablets 30 count bottle

Losartan Potassium 50mg Tablets 30 count bottle

Lot and Expiration Date Location

Lot and Expiration Date Location

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 19194
Status: Active
Sold By: Clinics and pharmacies nationwide as a prescribed medicine from July 2018 through August 2019. The container was included in the price of the medication, which varied based on quantities prescribed, health insurance terms and other factors.
Distributor: Sandoz Inc., of Princeton, N.J.
Manufactured In: Slovenia
Units Affected: About 636,000
Distributed To: Nationwide
Contact: Sandoz at 800-525-8747 from 8:30 a.m. to 5 p.m. ET Monday to Friday or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices.”
Agency Last Updated: August 29, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response