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CPSC recall · Reported January 31, 2013

Triaminic and Theraflu Products Recalled Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning

These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestio…

Recall #
13114
Affected scope
About 2.3 Million
Verify with CPSC →
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Novartis Consumer Health Inc., of Parsippany, Nj recalled This recall involves Triaminic® Syrups and Theraflu Warming Relief® Syrups for coughs, co….

Triaminic and Theraflu Products Recalled Due to Failure to Meet Child-Resistant Closure R… was recalled by Novartis Consumer Health Inc., of Parsippany, Nj in January 31, 2013. Reason: These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the…. Remedy: Consumers should immediately stop using the recalled product and contact Novartis for ins…. Verify recall #13114 with the CPSC before acting.

The recall

Novartis Consumer Health Inc., of Parsippany, Nj issued this CPSC recall-These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the….

None
agency class
January 31, 2013
reported

Sourced from official CPSC enforcement records. Verify recall #13114 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 Triaminic® Syrups and Theraflu Warming Relief® Syrups for coughs, colds and fevers. There are 24 types of these two products included in the recall. A complete list of products, lot numbers and National Drug Codes (NDC) can be found at www.novartisOTC.com. Lot numbers are located on the bottom panel of the box and on the left side of the label on the bottle. The NDC number is located on the upper right corner of the front panel of the Triaminic Syrups box and the upper left corner of the Theraflu Warming Relief Syrups bottle.

Reason for recall

These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning. These products contain acetaminophen and diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.

Remedy, what to do

Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.

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 13114
Date reported January 31, 2013
Date initiated January 31, 2013
Recalling firm Novartis Consumer Health Inc., of Parsippany, Nj
Affected scope About 2.3 Million
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 stop using the recalled product and contact Novartis for instructions on how to return the product f…

  • Check the recall number (13114) 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 Triaminic® Syrups and Theraflu Warming Relief® Syrups for coughs, colds and fevers. There are 24 types of these two products included in the recall. A complete list of products, lot numbers and National Drug Codes (NDC) can be found at www.novartisOTC.com. Lot numbers are located on the bottom panel of the box and on the left side of the label on the bottle. The NDC number is located on the upper right corner of the front panel of the Triaminic Syrups box and the upper left corner of the Theraflu Warming Relief Syrups bottle.. Recalled by Novartis Consumer Health Inc., of Parsippany, Nj. Units affected: About 2.3 Million.
Why was this product recalled?
These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning. These products contain acetaminophen and diphenhydramine which are required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.
What should consumers do?
Consumers should immediately stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund.
Which agency issued this recall?
This recall was issued by the CPSC on January 31, 2013. CPSC does not publish a hazard classification for this recall. Recall number: 13114.
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.

Nationwide recalls with similar severity or category timing

Consumer-product notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: CPSC, reported January 31, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026