Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles furt…

Recall date

September 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0033-2025

FDA classification

Class III

Brand / firm

Denison Pharmaceuticals, LLC

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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