Home/Recalls/FDA-D-0466-2026
FDA DrugsClass II

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar...

Published: April 22, 2026Recall ID: D-0466-2026Category: 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

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

Additional Source Details

FieldValue
CityXiamen
StateN/A
Openfda › Upc › 10635515993372
Openfda › Upc › 2635515993372
Openfda › UniiL7T10EIP3A
Openfda › RouteORAL
Openfda › Rxcui359751
Openfda › Spl id47189e74-0106-9a03-e063-6394a90addf4
Openfda › Brand nameQUALITY CHOICE
Openfda › Spl set id2307f3a7-f6e7-8a5d-e063-6394a90ab7eb
Openfda › Package ndc › 183698-616-25
Openfda › Package ndc › 26355159933
Openfda › Product ndc83698-616
Openfda › Generic nameCOUGH DROPS HONEY LEMON SUGAR FREE
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 # 20240720, Exp Date: 07/20/2026, Lot # 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