FDA Drugs recall ·
Kids' Cough and Chest Congestion (Dextromethorphan HBr… recall
- Recall number
- D-0034-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Denison Pharmaceuticals, LLC
1 Powder Hill Rd, Lincoln, RI, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 105,048 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0034-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.