Class II — Potential Health Hazard

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

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 Recalled by Glaxosmithkline Consumer Healthcare Holdings Due to Labeling: Lacks Warning or Rx Legend- Certain lots...

Date: March 16, 2020
Company: Glaxosmithkline Consumer Healthcare Holdings
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 Glaxosmithkline Consumer Healthcare Holdings directly.

Affected Products

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

Quantity: 566 blister packs

Why Was This Recalled?

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Where Was This Sold?

Product was distributed throughout the United States, including Puerto Rico.

About Glaxosmithkline Consumer Healthcare Holdings

Glaxosmithkline Consumer Healthcare Holdings has 16 total recalls tracked by RecallDetector.

Related Recalls

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