Cough Medicine Recall: Undeclared Alcohol in Wal-Tussin DM
Wal-Tussin DM cough medicine is being recalled because the product contains alcohol that was not declared on the label. Approximately 40,000–50,000 bottles distributed in Illinois are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored 1–2. This is a labeling defect (undeclared excipient) with no reported illnesses or injuries in the source material. Undeclared alcohol is a health-relevant issue for certain consumers, but the theoretical nature of the hazard and absence of reported harm place this in the Moderate category per the rubric.
Plain-English summary
AptaPharma Inc. is recalling Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, due to an undeclared excipient—alcohol—in the formulation. The product was distributed by Walgreen Co. in Illinois.
The product label does not identify alcohol as an ingredient. This omission may affect consumers who avoid alcohol due to medical conditions, medications that interact with alcohol, religious observance, or personal preference. Alcohol content was not specified in the source material.
Consumers who have this product should stop using it. Those with questions about the recall may contact Walgreen Co. or the manufacturer. This is a Class III recall by the FDA.
The recalled product
- Product
- Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
- Manufacturer
- AptaPharma Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed in 1 state:
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