CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Mucinex Fast Max DM Max, Maximum Strength recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, For, distributed nationwide in the US. The recall was initiated on 15 Apr 2015 and the FDA has classified it as Class II.
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-1369-2015
- FDA event ID
- 71013
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Manufacturer
- Reckitt Benckiser LLC
- Classification
- Class II
- 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 DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
Where it was distributed
Nationwide
Questions about this recall
Is Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, For recalled?
Yes. Reckitt Benckiser recalled Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, For on 15 Apr 2015. The recall is Class II and its status is Terminated. Recall number D-1369-2015.
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: AA189 1/31/2017 MDM0036 9/30/2016 MDM0039 11/30/2016 MDM0042 11/30/2016 MDM0043 11/30/2016 MDM0044 11/30/2016 MDM0045 11/30/2016 MDM0046 11/30/2016 MDM0047 11/30/2016 MDM0048 11/30/2016 MDM0049 12/31/2016 MDM0050 12/31/2016 MDM0052 12/31/2016 MDM0053 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Reckitt Benckiser
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Durex Real Feel, synthetic polisoprene male condom recalled | Reckitt Benckiser | Other | Nationwide |
| Device | CLASS II | Durex Pleasure Pack, synthetic polisoprene male condom recalled | Reckitt Benckiser | Other | Nationwide |
| Device | CLASS II | Polyisoprene condomns recalled by Reckitt Benckiser | Reckitt Benckiser | Device Malfunction | NY |
| Device | CLASS II | Durex Real Feel Polyisoprene Condoms recalled by Reckitt Benckiser | Reckitt Benckiser | Other | Nationwide |
| Device | CLASS II | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms recalled | Reckitt Benckiser | Labeling Errors | Nationwide |
Other Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength recalledMucinex Fast-max | Reckitt Benckiser | Packaging Defects | Nationwide |