# FDA recall D-0586-2016

> **Perrigo Company PLC** · Class II · drug recall initiated 2016-01-08.

## Product

Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.

## Reason for recall

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0586-2016
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-08
- **Report date:** 2016-02-03
- **Termination date:** 2016-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0586-2016

## Citation

> AI Analytics. FDA recall D-0586-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0586-2016. Source: US FDA. Licensed CC0.

---

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