Recall archive / FDA drug enforcement
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles f... — FDA record D-0034-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Denison Pharmaceuticals, LLC
- Quantity
- 105,048 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0034-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 13, 2024
- Recall initiation date
- Sep 25, 2024
- Center classification date
- Nov 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.