Mucinex Fast-Max DM Max Recalled for Missing Drug Facts Labeling
Reckitt Benckiser is recalling Mucinex Fast-Max DM Max bottles because the back label is missing active ingredients and safety warnings.
What this means for you
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 II and involves a labeling error where safety warnings are missing, which fits the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
Reckitt Benckiser LLC is recalling 416,220 bottles of Mucinex Fast-Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, for ages 12+. The product is distributed nationwide.
The recall is due to a labeling error where the back of the bottle, which contains the Drug Facts labeling, is missing certain active ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. Consequently, certain safety warnings associated with those ingredients may also be missing. The front of the label is correctly labeled.
Consumers should check their bottles for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the description, consumers should stop using it and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE)
- Brand
- MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cold and Flu
- Hazard
- Affected units
- 416,220
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)
- 0363824014777
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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