Class III Recall

Denison Pharmaceuticals, LLC

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
Reason
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Classification
Class III
Status
Ongoing
Lot
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Denison Pharmaceuticals, LLC — Class III Recall | MedicineWatch US