← FDA ENFORCEMENT
D-0461-2026Class II

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Recalling firm
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Product type
Drug
Status
Ongoing
Report date
2026-04-22
Distribution
US Nationwide.
Firm state
N/A
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

Product description

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085

Code / lot info

Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.