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.

Headache & Congestion Sinus Relief (acetaminophen 250 mg Recalled by Ultra Seal Corporation Due to cGMP deviations

Date: January 24, 2022
Company: Ultra Seal Corporation
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 Ultra Seal Corporation directly.

Affected Products

Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02

Quantity: 5,741,384 packets

Why Was This Recalled?

cGMP deviations

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ultra Seal Corporation

Ultra Seal Corporation has 66 total recalls tracked by RecallDetector.

Related Recalls

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