Denison Pharmaceuticals, LLC recalls Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt

Recalled November 13, 2024 · FDA recall D-0034-2025 · Denison Pharmaceuticals

Hazard

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

Units

105,048 bottles

Sold at

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

Description

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

Product

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

Manufacturer(s)

Denison Pharmaceuticals, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →