Triaminic® Syrups and Theraflu Warming Relief® Syrups

Class II - Moderate

What Should You Do?

  1. Check if you have this product:
    (About 2.3 Million)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Report problems: Report any issues to the FDA's Safety Reporting Portal.

Recall Details

Company:
Novartis Consumer Health Inc., of Parsippany, NJ
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.
Classification:
Class II - Moderate

Products that might cause a temporary health problem, or pose a slight threat of a serious nature.

Status:
ongoing
Hazard:
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.

Product Images

Triaminic® Syrups and Theraflu Warming Relief® Syrups

Product Information

Full 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.

Product Codes/Lot Numbers:

(About 2.3 Million)

Official Source

Always verify recall information with the official CPSC source:

View on CPSC.gov

CPSC Recall Number: 13114