# FDA recall D-1365-2015

> **Reckitt Benckiser LLC** · Class I · drug recall initiated 2015-04-15.

## Product

Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1365-2015
- **Recalling firm:** Reckitt Benckiser LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-15
- **Report date:** 2015-09-02
- **Termination date:** 2018-03-09

- **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-1365-2015

## Citation

> AI Analytics. FDA recall D-1365-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1365-2015. Source: US FDA. Licensed CC0.

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