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CPSC recall · Reported August 29, 2019

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

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Recall #
19194
Affected scope
About 636,000
Verify with CPSC →
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Sandoz Inc., of Princeton, N.j. recalled This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe….

Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure … was recalled by Sandoz Inc., of Princeton, N.j. in August 29, 2019. Reason: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, po…. Remedy: Consumers should immediately secure the medications to keep them out of the sight and rea…. Verify recall #19194 with the CPSC before acting.

The recall

Sandoz Inc., of Princeton, N.j. issued this CPSC recall-The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, po….

None
agency class
August 29, 2019
reported

Sourced from official CPSC enforcement records. Verify recall #19194 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. Consumers holding this product should act on the agency's documented remedy above rather than relying on general guidance.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448

Product description

This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers. The recalled bottles have "Sandoz," the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels. The recall includes the following: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Ezetimibe 10mg Tablets 0781-5690-31 JE4491 Aug-2020 30 count bottle JE4492 Aug-2020 JE4493 Aug-2020 JE4495 Aug-2020 JG0308 Sep-2020 JG0310 Sep-2020 JG0311 Sep-2020 JG0312 Sep-2020 JG5061 Sep-2020 JG5063 Sep-2020 JK8921 Oct-2020 JK8922 Oct-2020 JK8923 Oct-2020 JK8924 Oct-2020 JL5535 Oct-2020 JM2253 Oct-2020 JM2254 Oct-2020 JM2255 Oct-2020 JM2257 Oct-2020 JM2258 Oct-2020 JM2259 Oct-2020 JM5986 Oct-2020 JM5987 Oct-2020 Ezetimibe 10mg Tablets 0781-5690-92 JE4481 Aug-2020 90 count bottle JG0249 Sep-2020 JK8989 Oct-2020 JN0764 Jan-2021 Losartan Potassium 50mg Tablets 0781-5701-31 HV9471 Feb-2020 30 count bottle

Reason for recall

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Remedy, what to do

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.

Recall Profile

Structured summary of the CPSC recall record
Attribute Value
Agency U.S. Consumer Product Safety Commission
Severity class Not classified by agency
Status Active
Recall number 19194
Date reported August 29, 2019
Date initiated August 29, 2019
Recalling firm Sandoz Inc., of Princeton, N.j.
Affected scope About 636,000
Distribution Not disclosed
Official source CPSC notice →

Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.

What to do with this recall

Consumers should immediately secure the medications to keep them out of the sight and reach of children and contact Sandoz for a …

  • Check the recall number (19194) and product description against the item you own. Search the archive
  • Confirm the current status and remedy on the official CPSC notice before acting. CPSC notice
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official CPSC record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers. The recalled bottles have "Sandoz," the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels. The recall includes the following: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Ezetimibe 10mg Tablets 0781-5690-31 JE4491 Aug-2020 30 count bottle JE4492 Aug-2020 JE4493 Aug-2020 JE4495 Aug-2020 JG0308 Sep-2020 JG0310 Sep-2020 JG0311 Sep-2020 JG0312 Sep-2020 JG5061 Sep-2020 JG5063 Sep-2020 JK8921 Oct-2020 JK8922 Oct-2020 JK8923 Oct-2020 JK8924 Oct-2020 JL5535 Oct-2020 JM2253 Oct-2020 JM2254 Oct-2020 JM2255 Oct-2020 JM2257 Oct-2020 JM2258 Oct-2020 JM2259 Oct-2020 JM5986 Oct-2020 JM5987 Oct-2020 Ezetimibe 10mg Tablets 0781-5690-92 JE4481 Aug-2020 90 count bottle JG0249 Sep-2020 JK8989 Oct-2020 JN0764 Jan-2021 Losartan Potassium 50mg Tablets 0781-5701-31 HV9471 Feb-2020 30 count bottle. Recalled by Sandoz Inc., of Princeton, N.j.. Units affected: About 636,000.
Why was this product recalled?
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
What should consumers do?
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.
Which agency issued this recall?
This recall was issued by the CPSC on August 29, 2019. CPSC does not publish a hazard classification for this recall. Recall number: 19194.
How do I report an injury from a recalled product?
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.

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This recall: CPSC, reported August 29, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

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