FDA DrugsClass II
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free...
Published: April 22, 2026Recall ID: D-0461-2026Category: drugsCountry: US
Reason for Recall / Hazard
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 & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Xiamen |
| State | N/A |
| Openfda › Upc | 383173000085 |
| Openfda › Unii | L7T10EIP3A |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 359751 |
| Openfda › Spl id | 4deebeae-8aca-d791-e063-6394a90ae31f |
| Openfda › Brand name | MGC HEALTH |
| Openfda › Spl set id | 23079537-1c06-1373-e063-6394a90a37d2 |
| Openfda › Package ndc › 1 | 83698-125-25 |
| Openfda › Package ndc › 2 | 83698-125-70 |
| Openfda › Package ndc › 3 | 3831730000 |
| Openfda › Product ndc | 83698-125 |
| Openfda › Generic name | COUGH DROPS HONEY SUGAR-FREE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | MENTHOL |
| Openfda › Manufacturer name | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. |
| Openfda › Application number | M012 |
| Openfda › Is original packager | true |
| Event id | 98648 |
| Address 1 | No. 2018 |
| Address 2 | 2 Jietou Road |
| Code info | Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026. |
| Postal code | N/A |
| Report date | 20260422 |
| Product type | Drugs |
| Product 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | Letter |
| Center classification date | 20260410 |
Overview
- Recalling FirmXiamen Kang Zhongyuan Biotechnology Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.