Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
caring mill (Menthol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
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.
Affected NDC
83698-0421-90
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| caring mill Cough drops CHERRY Menthol NDC 83698-0421 |
, UNSPECIFIED FORM 5.8 mg/1 | Lozenge Oral |
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | OTC |
- Recalling firm
- Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
- Origin
- N/A, China
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0458-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Other recalls by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
All 2026 recalls
Class II · Moderate risk
QC Quality Choice
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.
Class II · Moderate risk
QC Quality Choice
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.
Class II · Moderate risk
QC Quality Choice
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.
Class II · Moderate risk
QC Quality Choice
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.
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