Home/Recalls/FDA-D-0458-2026
FDA DrugsClass II

caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-...

Published: April 22, 2026Recall ID: D-0458-2026Category: 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

caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.

Additional Source Details

FieldValue
CityXiamen
StateN/A
Openfda › Upc810025928407
Openfda › UniiL7T10EIP3A
Openfda › RouteORAL
Openfda › Rxcui476973
Openfda › Spl id46dc0782-d1b1-12e8-e063-6394a90acb99
Openfda › Brand nameCARING MILL COUGH DROPS CHERRY
Openfda › Spl set id274a28aa-00e9-8b9d-e063-6394a90ace2a
Openfda › Package ndc › 183698-421-90
Openfda › Package ndc › 28100259284
Openfda › Product ndc83698-421
Openfda › Generic nameMENTHOL
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameMENTHOL, UNSPECIFIED FORM
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