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.

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 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

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Quantity: 313,000 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