Class III — Low Risk

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

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg Recalled by Denison Pharmaceuticals, LLC Due to Crystallization: Lack of uniformity - a change in...

Date: September 25, 2024
Company: Denison Pharmaceuticals, LLC
Status: Ongoing
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 Denison Pharmaceuticals, LLC directly.

Affected Products

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

Quantity: 72,648 bottles

Why Was This Recalled?

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Where Was This Sold?

Product was distributed to two accounts that may have distributed the product further to the Retail Level.

About Denison Pharmaceuticals, LLC

Denison Pharmaceuticals, LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

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