D-0033-2025Class III

Denison Pharmaceuticals, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-11-13

Distribution

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

Firm state

Product quantity

72,648 bottles

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

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

Code / lot info

Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →