CLASS I Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Mucinex Fast-Max Cold & Sinus, Maximum Strength recalled
Reckitt Benckiser is recalling Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever, 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
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-1365-2015
- 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
- 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 & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, 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 63824-016-66, UPC 63824-01665-8
Where it was distributed
Nationwide
Questions about this recall
Is Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever recalled?
Yes. Reckitt Benckiser recalled Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever on 15 Apr 2015. The recall is Class I and its status is Terminated. Recall number D-1365-2015.
Why was it recalled?
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.
Which lots are affected?
Lot #: Exp: MCS0019 7/31/2016 MCS0020 7/31/2016 MCS0021 7/31/2016 MCS0022 8/31/2016 MCS0023 8/31/2016 MCS0024 9/30/2016 MCS0025 9/30/2016 MCS0026 9/30/2016 MCS0027 11/30/2016 MCS0028 10/31/2016 MCS0029 10/31/2016 MCS0030 12/31/2016 MCS0031 12/31/2016 MCS0032 12/31/2016 MCS0033 12/31/2016
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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