FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
FDA refuses entry of OnabotulinumtoxinA from South Korea.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 21, 2026, in the Aesthetic Injectables category, naming ONABOTULINUMTOXINA.
An import refusal marks a shipment of ONABOTULINUMTOXINA 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
- ONABOTULINUMTOXINA
- Recorded
- August 21, 2026
What this means for your practice — the step to take, the deadline to calendar or the supplier detail to check, where the change calls for one — 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
- Huons Global Co. Ltd
- Origin
- Jecheon-Si, South Korea
- Product
- Onabotulinumtoxina
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Aug 21, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3014451362
- FDA shipment ID
- 1FX-5149409-4/10002/1B
Why FDA refused it
Unapproved New Drug505(a), 801(a)(3); UNAPPROVED NEW DRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FDA charge codes on this record: 75 (Unapproved New Drug). 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-5149409-4/10002/1B (or firm FEI 3014451362), refused Aug 21, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Huons Global Co. Ltd · Jecheon-Si · drug product · refused as unapproved new drug
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