# FDA recall D-1361-2020

> **Glaxosmithkline Consumer Healthcare Holdings** · Class II · drug recall initiated 2020-06-16.

## Product

Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.

## Reason for recall

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-1361-2020
- **Recalling firm:** Glaxosmithkline Consumer Healthcare Holdings
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-16
- **Report date:** 2020-07-08
- **Termination date:** 2022-06-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1361-2020

## Citation

> AI Analytics. FDA recall D-1361-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1361-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
