Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling
Reckitt Benckiser is recalling Mucinex Fast Max liquid bottles because the back label is missing active ingredients and safety warnings.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe) due to the potential for serious adverse health consequences from missing safety warnings.
Plain-English summary
Reckitt Benckiser LLC is recalling 561,390 bottles of Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength. The product is distributed nationwide and is available in two 6 fl oz (180 mL) bottles per package, intended for ages 12 and older.
The recall is due to a labeling error where the back of the bottle, which contains the Drug Facts panel, is missing certain active ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. Consequently, specific safety warnings associated with these ingredients may also be missing from the label.
Consumers should stop using the product and check the lot numbers and expiration dates on their bottles against the list provided by the FDA. Affected lot numbers include WO00707825, WO00713226, WO00715310, WO00715505, WO00721174, WO00721177, WO00726860, WO00726862, WO00726952, WO00728861, WO00728878, and WO00728879.
The recalled product
- Product
- Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC…
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cold & Flu
- Affected units
- 561,390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Reckitt Benckiser LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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