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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74965

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 03, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Reckitt Benckiser LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

D-1517-2016
Recall number
D-1517-2016
Initiated
August 03, 2016
Classification
Class III
Status
Terminated
Recalling firm
Reckitt Benckiser LLC
Quantity
738 boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

WO00809739, 9/2017

Distribution pattern

FL, MA and NJ