Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling
Reckitt Benckiser is recalling Mucinex Fast Max liquid bottles where 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 according to the rubric.
Plain-English summary
Reckitt Benckiser LLC is recalling 200,688 bottles of Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, 6 fl oz (180 mL) bottles. The product is distributed nationwide and is 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 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 it and contact Reckitt Benckiser for a refund or replacement.
The recalled product
- Product
- Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC…
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cough & Cold
- Affected units
- 200,688
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Reckitt Benckiser LLC
See all →- HighDurex Real Feel Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- HighDurex Pleasure Pack Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- HighDurex Synthetic Polyisoprene Condoms Recalled for Burst Pressure Concerns
FDA (Devices) · 2018-10-17
- HighDurex Real Feel Polyisoprene Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2018-10-03
- ModerateDurex Condoms Recalled for Missing Benzocaine Labeling Information
FDA (Devices) · 2017-03-01
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateMucinex Sinus-Max Day Night Recalled for Labeling Errors
FDA (Drugs) · 2016-09-28
- LowMucinex DM Recalled for Defective Pouch Seal
FDA (Drugs) · 2015-04-29
- LowAaron Industries Recalls Select Brand Cough Control CF Max Due to Precipitate
FDA (Drugs) · 2013-03-13
- SevereOTC Cough and Cold Drug Recalled for Microbial Contamination
FDA (Drugs) · 2021-12-29
- ModerateOTC cough and congestion medication recalled for crystallization
FDA (Drugs) · 2024-11-13
- LowNovartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant
FDA (Drugs) · 2014-01-22