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.

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 Recalled by Novartis Consumer Health Due to Defective container: products are packaged in pouches which...

Date: June 6, 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

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm

Quantity: 472,000 pouches

Why Was This Recalled?

Defective container: products are packaged in pouches which may not have been fully sealed

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