CLASS III Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Mucinex Sinus-Max Day Night, 60 caplets recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Mucinex Sinus-Max Day Night, 60 caplets, distributed in Florida, Massachusetts, New Jersey. The recall was initiated on 3 Aug 2016 and the FDA has classified it as Class III.
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-1517-2016
- FDA event ID
- 74965
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Aug 2016
- FDA classified
- 22 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 3 Aug 2016 | Recall initiated by company | |
| 22 Sep 2016 | Classified by FDA | +50 days |
| 28 Sep 2016 | Published in enforcement report | +6 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 Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Product as listed by the FDA
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Where it was distributed
FL, MA and NJ
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Which lots are affected?
WO00809739, 9/2017
Where was it sold?
FL, MA and NJ
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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