Severity
Moderate
ModerateActive
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.
Sandoz Inc., of Princeton, N.j. recalled This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe… - a moderate-severity action.
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 moderate-severity CPSC recall-The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, po….
- Moderate
- severity level
- 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 CPSC action (record #19194) was formally reported on August 29, 2019. It is classified under Moderate severity, with a current status of Active. Sandoz Inc., of Princeton, N.j. is listed as the recalling firm. Federal records list the affected scope as About 636,000.
The documented reason for this recall is: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: 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 se… - consumers holding this product should act on that instruction 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
About 636,000
Related Recalls
6
0 from same agency
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
| Attribute | Value |
|---|---|
| Agency | U.S. Consumer Product Safety Commission |
| Severity class | Moderate |
| 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. Severity: Moderate. Recall number: 19194.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (19194) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: CPSC, reported August 29, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.