CLASS I Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report

Mucinex Fast Max Day Time Severe Cold recalled by Reckitt Benckiser

Reckitt Benckiser is recalling Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - bottles, distributed nationwide in the US. The recall was initiated on 15 Apr 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesWO00726864 6/30/2016 WO00737979 1/31/2017 WO00740405 1/31/2017 WO00706571 7/31/2016 WO00707442 7/31/2016 WO00707443 7/31/2016 WO00707444 7/31/2016 WO00707822 7/31/2016 WO00709953 7/31/2016 WO00709955 6/30/2016 WO00720780 7/31/2016 WO00721052 7/31/2016 WO00721170 7/31/2016 WO00721171 7/31/2016 WO00726865 7/31/2016 WO00728864 7/31/2016 WO00728865 12/31/2016 WO00728866 12/31/2016 WO00730003 12/31/2016 WO00730004 12/31/2016 WO00735142 12/31/2016 WO00736753 12/31/2016 WO00737477 1/31/2017 WO00738556 12/31/2016 WO00739050 12/31/2016 WO00740406 1/31/2017

Quantity recalled561,390 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1366-2015
FDA event ID: 71013
Recalling firm: Reckitt Benckiser, Parsippany, NJ
Classification: Class I
Status: Terminated
Recall initiated: 15 Apr 2015
FDA classified: 25 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Cold & Cough Medicine

Timeline

15 Apr 2015	Recall initiated by company
25 Aug 2015	Classified by FDA	+132 days
2 Sep 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

WO00726864 6/30/2016 WO00737979 1/31/2017 WO00740405 1/31/2017 WO00706571 7/31/2016 WO00707442 7/31/2016 WO00707443 7/31/2016 WO00707444 7/31/2016 WO00707822 7/31/2016 WO00709953 7/31/2016 WO00709955 6/30/2016 WO00720780 7/31/2016 WO00721052 7/31/2016 WO00721170 7/31/2016 WO00721171 7/31/2016 WO00726865 7/31/2016 WO00728864 7/31/2016 WO00728865 12/31/2016 WO00728866 12/31/2016 WO00730003 12/31/2016 WO00730004 12/31/2016 WO00735142 12/31/2016 WO00736753 12/31/2016 WO00737477 1/31/2017 WO00738556 12/31/2016 WO00739050 12/31/2016 WO00740406 1/31/2017

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 71013

This product is part of a recall event; the main page for the event is Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015	CLASS I	Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength recalledMucinex Fast-max	Reckitt Benckiser	Packaging Defects	Nationwide
2 Sep 2015	CLASS I	Mucinex Fast Max Night Time Cold & Flu, Maximum Strength recalled	Reckitt Benckiser	Packaging Defects	Nationwide
2 Sep 2015	CLASS I	Mucinex Fast-Max Cold & Sinus, Maximum Strength recalled	Reckitt Benckiser	Packaging Defects	Nationwide
2 Sep 2015	CLASS I	Mucinex Fast Max Severe Congestion & Cough recalled by Reckitt Benckiser	Reckitt Benckiser	Packaging Defects	Nationwide
2 Sep 2015	CLASS I	Mucinex Fast Max Day Time Severe Congestion & Cough Night recalled	Reckitt Benckiser	Packaging Defects	Nationwide
2 Sep 2015	CLASS II	Mucinex Fast Max DM Max, Maximum Strength recalled by Reckitt BenckiserMucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu	Reckitt Benckiser	Packaging Defects	Nationwide

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