PlainRecalls

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

Reported: January 31, 2013 Initiated: January 31, 2013 #13114 About 2.3 Million units

Novartis Consumer Health Inc., of Parsippany, NJ issued this CPSC recall on January 31, 2013. Classified as Moderate severity. Approximately About 2.3 Million units are affected. The recall was issued because: These child-resistant caps can fail to function properly and enable the cap to be removed by a child with the tamper-ev…. This recall notice is sourced from official CPSC enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This CPSC action (record #13114) was formally reported on January 31, 2013. It is classified under Moderate severity, with a current status of Active. Novartis Consumer Health Inc., of Parsippany, NJ is listed as the recalling firm. Federal records indicate About 2.3 Million units are affected.

The documented reason for this recall is: 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 … 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 stop using the recalled product and contact Novartis for instructions on how to return the product for a full refund. — consumers holding this product should act on that instruction rather than relying on general guidance.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 1 were also issued by CPSC. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

About 2.3 Million

Related Recalls

6

1 from same agency

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

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 Moderate
Status Active
Recall number 13114
Date reported January 31, 2013
Date initiated January 31, 2013
Recalling firm Novartis Consumer Health Inc., of Parsippany, NJ
Units affected About 2.3 Million
Distribution Not disclosed

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

Scale of Impact

About 2.3 Million units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Consumer Product Safety Commission filings.

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. Severity: Moderate. Recall number: 13114.
How do I check if my product is affected by a recall?
Check the product description and recall number (13114) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).