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

Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength recalled

Reckitt Benckiser is recalling Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain, 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: MCF0048 7/31/2016 MCF0051 7/31/2016 MCF0052 8/31/2016 MCF0053 8/31/2016 MCF0054 8/31/2016 MCF0055 8/1/2016 MCF0056 8/31/2016 MCF0057 8/31/2016 MCF0058 8/31/2016 MCF0059 10/1/2016 MCF0060 8/31/2016 MCF0061 8/31/2016 MCF0062 8/31/2016 MCF0063 9/30/2016 MCF0064 9/30/2016 MCF0065 9/30/2016 MCF0066 9/30/2016 MCF0067 9/30/2016 MCF0068 9/30/2016 MCF0069 10/31/2016 MCF0070 10/31/2016 MCF0071 10/31/2016 MCF0072 10/31/2016 MCF0073 10/31/2016 MCF0074 10/31/2016 MCF0075 10/31/2016 MCF0076 10/31/2016 MCF0077 10/31/2016

NDC63824-015

UPC0363824015651

Quantity recalled495036 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-1363-2015
FDA event ID: 71013
Recalling firm: Reckitt Benckiser, Parsippany, NJ
Brand: Mucinex Fast-max
Manufacturer: Reckitt Benckiser LLC
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: Pain Medication

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 Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: Exp: MCF0048 7/31/2016 MCF0051 7/31/2016 MCF0052 8/31/2016 MCF0053 8/31/2016 MCF0054 8/31/2016 MCF0055 8/1/2016 MCF0056 8/31/2016 MCF0057 8/31/2016 MCF0058 8/31/2016 MCF0059 10/1/2016 MCF0060 8/31/2016 MCF0061 8/31/2016 MCF0062 8/31/2016 MCF0063 9/30/2016 MCF0064 9/30/2016 MCF0065 9/30/2016 MCF0066 9/30/2016 MCF0067 9/30/2016 MCF0068 9/30/2016 MCF0069 10/31/2016 MCF0070 10/31/2016 MCF0071 10/31/2016 MCF0072 10/31/2016 MCF0073 10/31/2016 MCF0074 10/31/2016 MCF0075 10/31/2016 MCF0076 10/31/2016 MCF0077 10/31/2016

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

Reported	Class	Recall	Company	Reason	Where
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 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

Other Acetaminophen recalls

All 61

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength	Kenvue Brands	Other	Nationwide
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2024Drug	CLASS II	Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion	LNK International	Manufacturing (CGMP) Deviations	Nationwide