Class III โ€” Low Risk

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

Bronkaid Dual Action Formula Recalled by Bayer Healthcare, LLC Due to Labeling: Label lacks warning or Rx legend; Certain...

Date: December 7, 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

Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.

Quantity: 1,353,420 Blister Packs

Why Was This Recalled?

Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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