Theraflu Recall: What Parents Need to Know About the Safety Alert

If you are searching for information about a Theraflu recall, you may be concerned about whether your medication is safe to use — especially if children are in your home.

In coordination with the U.S. Consumer Product Safety Commission (CPSC), Novartis Consumer Health Inc. previously issued a voluntary recall of certain lots of Theraflu® Warming Relief® Syrups and Triaminic® Syrups due to a defect involving child-resistant caps.

The issue created a risk of accidental ingestion and potential poisoning.

Below, we explain what was recalled, why it happened, and what consumers should do.

Why Was Theraflu Recalled?

The Theraflu recall involved a defect in the child-resistant safety cap.

The problem:

The cap could be removed while the tamper-evident seal remained intact.

This meant:

The medication bottle appeared unopened
Children could potentially access the contents
The safety packaging failed to meet child-resistant standards

Because the products contain ingredients such as acetaminophen and diphenhydramine, accidental ingestion could lead to serious health consequences.

What Risk Did the Recall Present?

Under the Poison Prevention Packaging Act, medications containing certain active ingredients must include child-resistant packaging.

According to reports at the time of the recall:

12 children were able to unscrew the failed caps
4 children ingested the medication
1 child required medical attention

Even small amounts of these medications can pose serious risks to children, including liver toxicity and central nervous system effects.

Which Products Were Included in the Theraflu Recall?

The recalled products were manufactured prior to December 31, 2011 and sold between May 2010 and December 2011.

A total of 24 products were included in the recall.

Theraflu® Warming Relief Products:

Theraflu® Warming Relief Flu and Sore Throat, 8.3 oz.
Theraflu® Daytime Warming Relief Severe Cold and Cough, 8.3 oz.
Theraflu® Daytime/Nighttime Severe Cold & Cough Value Pack
Theraflu® Nighttime Warming Relief Severe Cold and Cough, 8.3 oz.
Theraflu® Warming Relief Cold and Chest Congestion, 8.3 oz.
Theraflu® Warming Relief Sinus and Cold, 8.3 oz.

Triaminic® Syrup Products:

Triaminic® Chest and Nasal Congestion, 4 oz
Triaminic® Cold and Allergy, 4 oz
Triaminic® Cough and Sore Throat, 4 oz.
Triaminic® Day Time Cold and Cough, 4 oz
Triaminic® Daytime/Nighttime Cold & Cough Club Pack
Triaminic® Daytime/Nighttime Cold & Cough Combo Pack
Triaminic® Dye-Free Long Acting Cough, 4 oz.
Triaminic® Fever Reducer Pain Reliever Bubblegum, 4 oz
Triaminic® Fever Reducer Pain Reliever Grape, 4 oz.
Triaminic® Fever Reducer Pain Reliever Infant Bubblegum, 2 oz.
Triaminic® Fever Reducer Pain Reliever Infant Grape, 2 oz.
Triaminic® Multi Symptom Fever, 3.4 oz.
Triaminic® Multi Symptom Fever, 4 oz.
Triaminic® Night Time Cold and Cough, 3.4 oz.
Triaminic® Night Time Cold and Cough, 4 oz.

How to Check If Your Product Was Recalled

To determine whether your Theraflu product was part of the recall:

Check the lot number on:
- The bottom of the box
- The left side of the bottle label
Locate the National Drug Code (NDC):
- Upper left corner of Theraflu box
- Lower right corner of Triaminic box

If your product matches the recalled lot numbers, it should not be used.

What Should You Do If You Have a Recalled Product?

If you have a recalled Theraflu or Triaminic product:

Stop using the medication immediately
Keep it out of reach of children
Contact the manufacturer for refund instructions
Follow return or disposal instructions provided

Manufacturer Contact Information:

Novartis Consumer Relationship Center
Phone: 1-866-553-6742
Hours: Mon–Sat, 8 a.m. – 12 a.m. ET

Consumers were eligible for full refunds at the time of the recall.

Symptoms of Accidental Ingestion in Children

If a child consumes medication containing acetaminophen or diphenhydramine, symptoms may include:

Drowsiness
Nausea or vomiting
Confusion
Rapid heartbeat
Abdominal pain
Liver injury (in severe cases)

Seek immediate medical attention or contact Poison Control (1-800-222-1222) if ingestion is suspected.

Has There Been a Recent Theraflu Recall?

As of this recall notice, the affected products were those manufactured prior to December 31, 2011.

Consumers searching for “Theraflu recall” should verify whether any new recalls have been issued through:

The U.S. Consumer Product Safety Commission (CPSC)
The FDA recall database
The manufacturer’s website

Recall information can change, and updated alerts may be issued in the future.

Legal Options After Injury From a Recalled Product

When manufacturers fail to provide adequate child-resistant packaging, serious injuries can occur.

If your child was harmed due to a defective or recalled product, you may have grounds for a product liability claim.

Potential claims may involve:

Defective packaging
Failure to warn
Design defects
Negligence in manufacturing

Our firm evaluates cases involving recalled medications and defective consumer products. If your child suffered injury related to a recalled Theraflu or Triaminic product, contact us for a confidential case review.

Frequently Asked Questions About the Theraflu Recall

Why was Theraflu recalled?

Certain lots were recalled due to defective child-resistant caps that could be opened while appearing sealed.

Was the medication itself contaminated?

The recall involved packaging defects, not contamination of the medication formula.

Are Theraflu products currently safe?

Only specific lots manufactured before December 31, 2011 were affected. Consumers should verify current safety through official recall sources.

What law requires child-resistant packaging?

The Poison Prevention Packaging Act requires certain medications to have child-resistant packaging to prevent accidental poisoning.

Final Thoughts

The Theraflu recall serves as an important reminder that even over-the-counter medications must meet strict packaging and safety standards. When child-resistant mechanisms fail, the consequences can be serious.

If you believe a recalled product caused injury to your child, legal options may be available.

Contact our office today for a free and confidential consultation.

Theraflu Recall: What Parents Need to Know About the Safety Alert