Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Kids' Cough and Chest Congestion
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
69676-0077-09
Compare with the code on your package — it is the most precise check available.
Drug: Guaifenesin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cough and Chest Congestion Maximum Strength Dextromethorphan HBr, Guaifenesin NDC 69676-0077 |
GUAIFENESIN 400 mg/20mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL | Suspension Oral |
Genexa Inc. | OTC |
- Recalling firm
- Denison Pharmaceuticals, LLC
- Origin
- RI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0034-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Guaifenesin recalls
See all
Class II · Moderate risk
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Other recalls by Denison Pharmaceuticals, LLC
All 2024 recalls
Class II · Moderate risk
Zapzyt
Chemical Contamination: Presence of benzene.
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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