FDA Announces Recall of MGC Health Cough Drops
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has initiated a recall of MGC Health Cough Drops due to potential quality issues from a manufacturing 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
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. It is a voluntary recall initiated by the firm, Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Which Products Are Affected
The affected product is MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, distributed by Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, with NDC: 83698-114-80 and UPC: 383173000030. Other package NDCs include 83698-114-30 and 3831730000. The lot number is 20240730 with an expiration date of 07/30/2026. The product quantity affected is N/A, and distribution is US Nationwide.
What You Should Do
Consumers should check for the affected product by lot number and contact the recalling firm, Xiamen Kang Zhongyuan Biotechnology Co., Ltd., as the initial notification was made via letter.
Why This Matters
This recall highlights potential quality concerns in over-the-counter drugs, affecting products distributed nationwide and classified as Class II, which may cause temporary or reversible health issues.
Source
FDA recall announcement for recall number D-0463-2026. Attribution: FDA.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,317 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.