Mucinex Sinus-Max Day Night: Label Error on Diphenhydramine Strength
Reckitt Benckiser recalls Mucinex Sinus-Max Day Night 60 caplets due to label error stating 25mg diphenhydramine instead of 12.5mg. Correct dosage may cause overdose risk.
Lower-risk 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.
Contact the company
What happened, in plain English
Reckitt Benckiser is recalling Mucinex Sinus-Max Day Night 60 caplets because the label incorrectly states 25mg diphenhydramine instead of 12.5mg. This could lead to an overdose if taken as directed. Read more at govinfonow.com/recall/42501-mucinex-sinus-max-day-night-label-error-on-diphenhydramine-strength.
Source Summary by GovInfoNow · govinfonow.com/recall/42501-mucinex-sinus-max-day-night-label-error-on-diphenhydramine-strength · Updated October 9, 2026 · FDA enforcement record: FDA #D-1517-2016
Cite this page
“Mucinex Sinus-Max Day Night: Label Error on Diphenhydramine Strength.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42501-mucinex-sinus-max-day-night-label-error-on-diphenhydramine-strength. Based on FDA recall #D-1517-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1517-2016%22&limit=1).
Why it’s dangerous
The label on the outer carton incorrectly states 25mg diphenhydramine instead of 12.5mg. This error could lead to taking too much medication, potentially causing an overdose.
Who’s affected
People who own or use Mucinex Sinus-Max Day Night 60 caplets with the incorrect labeling. Those taking the medication for allergies or cold symptoms are most at risk of overdose.
How to tell if you have this one
Check for the product with the label stating Diphenhydramine 25mg instead of 12.5mg. The product was distributed by Reckitt Benckiser in the US with UPC 363824951737 and NDC 63824-207-60.
- Brand
Reckitt Benckiser- Product
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC- Category
Drug
What to do — step by step
Check Label
Verify the diphenhydramine strength on the outer carton label; it should state 12.5mg, not 25mg.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “FL, MA and NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Massachusetts, New Jersey.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1517-2016 (August 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1517-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.