# FDA recall D-1517-2016

> **Reckitt Benckiser LLC** · Class III · drug recall initiated 2016-08-03.

## Product

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

## 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.

## Distribution

FL, MA and NJ

## Key facts

- **Recall number:** D-1517-2016
- **Recalling firm:** Reckitt Benckiser LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-03
- **Report date:** 2016-09-28
- **Termination date:** 2018-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2016

## Citation

> AI Analytics. FDA recall D-1517-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1517-2016. Source: US FDA. Licensed CC0.

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