Denison Pharmaceuticals, LLC: Drug Recall
Recall #D-0034-2025 · 09/25/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0034-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Denison Pharmaceuticals, LLC
- Status
- Ongoing
- Date Initiated
- 09/25/2024
- Location
- Lincoln, RI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,048 bottles
Reason for Recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Product Description
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
Distribution Pattern
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Other Recalls by Denison Pharmaceuticals, LLC
- Class II: Risk 02/24/2025
- Class III: Low Risk 09/25/2024
- Class II: Risk 05/28/2024
- Class II: Risk 05/03/2023
- Class II: Risk 05/03/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.