Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Midol Complete Recalled by Bayer Healthcare, LLC Due to Labeling: Label Mix-up: This recall was initiated after...

Date: April 26, 2012
Company: Bayer Healthcare, LLC
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 Bayer Healthcare, LLC directly.

Affected Products

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)

Quantity: 48,528 cartons

Why Was This Recalled?

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Where Was This Sold?

Product was distributed to 93 retail accounts/customers.

About Bayer Healthcare, LLC

Bayer Healthcare, LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

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