Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Theraflu Exte (dextromethorphan hydrobromide 20 mg Recalled by Novartis Consumer Health Due to Presence of Foreign Substance: The products are being...

Date: June 18, 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 Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.

Why Was This Recalled?

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

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.

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