Class II U.S. Food and Drug Administration

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based

Recall published 6 months ago

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.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0470-2026
Published
April 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
China
Lot / code info
Lot # 20240720, Exp Date: 07/20/2026.
UPC codes
635515999411

Products covered by this recall

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 635515999411

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 20240720

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07
  • 20
  • 2026. — N

NDC number

On the carton and again on the bottle or blister label.

  • 83698-620-30

Package size

Match the net weight or the piece count on the front of the pack.

  • 30 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — No. 2018, Xiamen

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Xiamen Kang Zhongyuan Biotechnology Co., Ltd. prescription… 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 635515999411; lot code 20240720; best-by date 07 or 20. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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