FDA import refusal: Lidocaine (South Korea)
FDA refuses entry of lidocaine from South Korea; verify your suppliers.
What changed & why it matters
Med Spa Radar recorded an FDA import refusal at the federal level, dated July 27, 2026, in the Aesthetic Injectables category, naming LIDOCAINE.
An import refusal marks a shipment of LIDOCAINE the FDA stopped at the U.S. border as violative — the gray-market corridor a med spa must never source injectables from. Foreign, unapproved, or misbranded product refused at import is exactly what surfaces when a practice buys outside verified US-licensed 503A/503B or FDA-registered channels.
- Type
- FDA Import Refusal
- Jurisdiction
- Federal
- Category
- Aesthetic Injectables
- Substance
- LIDOCAINE
- Recorded
- July 27, 2026
What this means for your specific practice — the exact step to take, the deadline to calendar, or the supplier detail to check — is in the member "what to do" below. This page is the free record of what changed and why it matters.
What to do
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The FDA record
- Firm
- Vivozon Pharmaceutical
- Origin
- Hwaseong, South Korea
- Product
- Lidocaine
- FDA classification
- Human Drugs
- Refused
- Jul 27, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3019906316
- FDA shipment ID
- 1FX-4073441-0/20002/1E
Why FDA refused it
Misbranding502(c); 801(a)(3) ;MISBRANDING
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FDA charge codes on this record: 472 (Misbranding). Definitions via the FDA Refusal Charges Reference.
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID 1FX-4073441-0/20002/1E (or firm FEI 3019906316), refused Jul 27, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Vivozon Pharmaceutical · Hwaseong · drug product · refused as misbranding
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Monitoring, not legal advice.