Home/Recalls/FDA-D-0457-2026
FDA DrugsClass II

exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Mentho...

Published: April 22, 2026Recall ID: D-0457-2026Category: 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

exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.

Additional Source Details

FieldValue
CityXiamen
StateN/A
Openfda › Upc614299398887
Openfda › UniiL7T10EIP3A
Openfda › RouteORAL
Openfda › Rxcui485287
Openfda › Spl id4718e578-22ea-6f9a-e063-6294a90a16b2
Openfda › Brand nameMENTHOL FLAVOR COUGH DROP
Openfda › Spl set id274a5551-4989-d8fe-e063-6394a90aeabf
Openfda › Package ndc › 183698-581-30
Openfda › Package ndc › 26142993988
Openfda › Product ndc83698-581
Openfda › Generic nameMENTHOL FLAVOR COUGH DROP
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameMENTHOL
Openfda › Manufacturer nameXiamen Kang Zhongyuan Biotechnology Co., Ltd.
Openfda › Application numberM012
Openfda › Is original packagertrue
Event id98648
Address 1No. 2018
Address 22 Jietou Road
Code infoLot # 20241030, Exp Date: 10/30/2026
Postal codeN/A
Report date20260422
Product typeDrugs
Product quantityN/A
Reason for recallThis 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 mandatedVoluntary: Firm initiated
Recall initiation date20260320
Initial firm notificationLetter
Center classification date20260410

Overview

  • Recalling FirmXiamen Kang Zhongyuan Biotechnology Co., Ltd.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide.
Official Agency Alert