Mucinex Fast-Max 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 agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Reckitt Benckiser LLC is recalling 495,036 bottles of Mucinex Fast-Max Cold, Flu & Sore Throat liquid. The product is distributed nationwide and is available in 6 fl oz (180 mL) bottles for ages 12 and older.
The recall was initiated due to a labeling error. While the front of the bottle is correctly labeled, 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 check their bottles for the affected lot numbers and expiration dates listed in the recall notice. If a bottle is affected, consumers should stop using the product and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- MUCINEX FAST-MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE)
- Brand
- MUCINEX FAST-MAX
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cold & Flu
- Affected units
- 495,036
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0363824015651
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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