Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Childrens Robitussin Honey Cough and Chest Congestion DM (Dextromethorphan Hbr, Guaifenesin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
Affected NDC
0031-8760-12
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 |
|---|---|---|---|---|
| Childrens Robitussin Honey Cough and Chest Congestion DM dextromethorphan HBr, guaifenesin NDC 00031-8760 |
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL; GUAIFENESIN 100 mg/10mL | Solution Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1361-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Other recalls by Glaxosmithkline Consumer Healthcare Holdings
All 2020 recalls
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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