Mgc Health Lozenge
FDA Recall NDC 83698-125
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mgc Health (NDC 83698-125). A significant event, classified as Class II, was initiated on Mar 20, 2026 by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
March 2026 Class II 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 Number
Class II Ongoing
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.
Mar 20, 2026
Apr 22, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98648
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
Batch or Lot Expiration Information
Lot# 20240524, Exp Date: 05/24/2026
Lot# 20240720, Exp Date: 07/20/2026
Lot# 20240730, Exp Date: 07/30/2026.
Affected Packages Involved in this Recall
83698-125-25Product
83698-125-70Product
3831730000Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
