MGC Health — Class II drug recall D-0462-2026
Ongoing recall by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., reported 2026-04-22, distributed nationwide. This recall is being initiated following FDA's recommendation based on certain observations noted during an Au
| Recall number | D-0462-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Xiamen, N/A, China |
| Recall initiated | 2026-03-20 |
| Classified | 2026-04-10 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00383173000047 |
| NDC | 83698-0114, 83698-0114-30, 83698-0114-80 |
| Lot numbers | 20240524 |
| Expiration dates | 2026-05-24 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0462-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.