FDA recall D-0465-2026

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

Product

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

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-0465-2026