Drug FDA Class II Ongoing cGMP deviation
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.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. Published Apr 22, 2026
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Xiamen Kang Zhongyuan Biotechnology Co., Ltd. or your place of purchase with questions, and see the source record below for full details.
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.
Affected products (1)
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.
CARING MILL COUGH DROPS CHERRY · N/A
NDC: 83698-421, 83698-421-90, 8100259284
Lot codes: 20241030
Code info: Lot # 20241030, Exp Date: 10/30/2026
Affected areas
Nationwide
Timeline
- InitiatedMar 20, 2026
- PublishedApr 22, 2026
- Recall number
- D-0458-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.