FDA recall D-0463-2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · drug

Product

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.

Reason for recall

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-03-20
Report date
2026-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Xiamen, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0463-2026