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.

Extra Strength Headache (acetaminophen 250 mg Recalled by Medique Products Due to CGMP Deviations: manufacturer recalled after an FDA inspection...

Date: December 6, 2021
Company: Medique Products
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 Medique Products directly.

Affected Products

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

Quantity: 6,639,838 tablets

Why Was This Recalled?

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medique Products

Medique Products has 3 total recalls tracked by RecallDetector.

Related Recalls

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