Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Theraflu Warming Relief Recalled by Novartis Consumer Health Due to Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Date: May 15, 2013
Company: Novartis Consumer Health
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novartis Consumer Health directly.

Affected Products

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

Quantity: 98,024/8-caplet packages and 557,548/24-caplet packages

Why Was This Recalled?

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novartis Consumer Health

Novartis Consumer Health has 60 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report