Recalls / Class III
Class IIID-0034-2025
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
- Brand name
- Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack
- Generic name
- Dextromethorphan Hbr, Guaifenesin, Acetaminophen, Doxylamine Succinate
- NDC
- 69676-0079
- FDA application
- M013
- Affected lot / code info
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Why it was recalled
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recalling firm
- Firm
- Denison Pharmaceuticals, LLC
- Manufacturer
- Genexa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Powder Hill Rd, N/A, Lincoln, Rhode Island 02865-4407
Distribution
- Quantity
- 105,048 bottles
- Distribution pattern
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Timeline
- Recall initiated
- 2024-09-25
- FDA classified
- 2024-11-01
- Posted by FDA
- 2024-11-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0034-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.