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

Mucinex Fast Max Day Time Severe Congestion & Cough Night recalled

Reckitt Benckiser is recalling Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum, 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 codesLot #: Exp: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30/2016 WO00715505 7/31/2016 WO00721174 9/30/2016 WO00721177 10/31/2016 WO00726860 10/31/2016 WO00726862 6/30/2016 WO00726952 8/31/2016 WO00728861 6/30/2016 WO00728878 7/31/2016 WO00728879 9/30/2016

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-1368-2015
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 Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: Exp: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30/2016 WO00715505 7/31/2016 WO00721174 9/30/2016 WO00721177 10/31/2016 WO00726860 10/31/2016 WO00726862 6/30/2016 WO00726952 8/31/2016 WO00728861 6/30/2016 WO00728878 7/31/2016 WO00728879 9/30/2016

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 Cold recalled by Reckitt Benckiser	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

More recalls from Reckitt Benckiser

All 15

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019Device	CLASS II	Durex Real Feel, synthetic polisoprene male condom recalled	Reckitt Benckiser	Other	Nationwide
20 Mar 2019Device	CLASS II	Durex Pleasure Pack, synthetic polisoprene male condom recalled	Reckitt Benckiser	Other	Nationwide
17 Oct 2018Device	CLASS II	Polyisoprene condomns recalled by Reckitt Benckiser	Reckitt Benckiser	Device Malfunction	NY
3 Oct 2018Device	CLASS II	Durex Real Feel Polyisoprene Condoms recalled by Reckitt Benckiser	Reckitt Benckiser	Other	Nationwide
1 Mar 2017Device	CLASS II	Durex Pleasure Pack . 3 ultra fine lubricated latex condoms recalled	Reckitt Benckiser	Labeling Errors	Nationwide