Recall of MGC Health Cough Drops Announced

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. is voluntarily recalling certain lots of MGC Health Cough Drops due to potential quality issues identified by the FDA during a facility inspection.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall Article

What Happened

This recall was initiated following FDA's recommendation based on observations noted during an August 15, 2025, inspection of the manufacturing facility that may affect product quality.

Which Products Are Affected

The affected products are MGC Health Menthol Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, in 25-count bags. Specific details include: NDC 83698-125-25, UPC 383173000085, package NDCs 83698-125-25 and 83698-125-70, and lots Lot# 20240524 with expiration date 05/24/2026, Lot# 20240720 with expiration date 07/20/2026, and Lot# 20240730 with expiration date 07/30/2026. The recall involves products distributed US Nationwide, with the quantity not specified.

What You Should Do

Consumers who have the affected products should follow the initial firm notification via letter and contact the recalling firm, Xiamen Kang Zhongyuan Biotechnology Co., Ltd., for further instructions.

Why This Matters

This recall addresses potential quality concerns in over-the-counter drugs, which could impact consumer safety, and it affects products distributed nationwide.

Source

FDA Recall Number: D-0461-2026. For more information, refer to the FDA website at https://www.fda.gov/.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. is voluntarily recalling certain lots of MGC Health Cough Drops due to potential quality issues identified by the FDA during a facility inspection.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.