Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling
Reckitt Benckiser is recalling Mucinex Fast Max Night Time Cold & Flu 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Reckitt Benckiser LLC is recalling 717,336 bottles of Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, 6 fl oz. (180 mL) bottles. The product is distributed nationwide and is intended for ages 12 and older. The recall involves specific lot numbers with expiration dates ranging from July 31, 2016, to December 31, 2017.
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, safety warnings associated with these ingredients may also be missing from the label.
Consumers should check their bottles for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ…
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cold & Flu
- Affected units
- 717,336
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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