Mucinex Sinus-Max Day Night Recalled for Labeling Errors
Reckitt Benckiser is recalling Mucinex Sinus-Max Day Night caplets because the outer carton lists incorrect drug strength and quantity.
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: The recall is classified as FDA Class III, which is typically associated with minor labeling errors or low-risk issues that are unlikely to cause adverse health consequences.
Plain-English summary
Reckitt Benckiser LLC is recalling 738 boxes of Mucinex Sinus-Max Day Night, 60 caplets, due to labeling errors on the outer carton. The product is distributed in Florida, Massachusetts, and New Jersey.
The recall was initiated because the label incorrectly states the strength of Diphenhydramine as 25 mg instead of the correct 12.5 mg. Additionally, the label incorrectly states the quantity as 30 daytime and 30 nighttime caplets, whereas the correct quantity is 36 daytime and 24 nighttime caplets.
Consumers who have this product should stop using it and contact the manufacturer for a refund or replacement. The affected product has the UPC 363824951737 and NDC 63824-207-60.
The recalled product
- Product
- Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
- Manufacturer
- Reckitt Benckiser LLC
- Hazard
- Affected units
- 738
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 (2)
- WO00809739
- 9/2017
Distribution
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