Menthol Flavor Cough Drop Recall Announced by FDA
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 Menthol Flavor 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.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
This recall was initiated following the FDA's recommendation based on certain observations noted during an inspection of the manufacturing facility on August 15, 2025, that may affect product quality.
Which Products Are Affected
The affected product is exchange select Menthol Cough Suppressant Oral Anesthetic Cough Drops, Menthol Flavor, in 30-count bags. It has the following details: NDC: 83698-581-30, UPC: 614299398887, Lot # 20241030, and Expiration Date: 10/30/2026. The recall involves products distributed US Nationwide, with the quantity listed as N/A.
What You Should Do
Consumers should contact the recalling firm, Xiamen Kang Zhongyuan Biotechnology Co., Ltd., for instructions. The product is manufactured for Medical Group Care, LLC, at 1035 Collier Center Way, STE 5, Naples, FL.
Why This Matters
This recall highlights potential quality concerns in over-the-counter drugs, affecting consumers nationwide who may have purchased these cough drops for relief.
Source
FDA recall notice for event ID 98648, attributed to the FDA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.