FDA Recall D-0462-2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Xiamen, N/A

Class II Ongoing 55 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.

Lot / code: Lot# 20240524, Exp Date: 05/24/2026.

Quantity: N/A

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.

Recall record

Recall number: D-0462-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2026-03-20
Classified by FDA Center: 2026-04-10
FDA published: 2026-04-22
Recalling firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Firm location: Xiamen, N/A, China

Drug identification

Brand name(s): MGC HEALTH
Generic name(s): COUGH DROPS HONEY
Manufacturer(s): Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
NDC(s): 83698-114
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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