FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
FDA refused entry of OnabotulinumtoxinA from South Korea.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 13, 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 13, 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.
Firm inspection: Voluntary Action Indicated
This firm’s most recent FDA inspection was classified Voluntary Action Indicated (VAI) — objectionable conditions FDA expects the firm to correct.
Source: FDA Data Dashboard inspection classifications (most recent, by firm FEI).
What to do
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The FDA record
- Firm
- Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)
- Origin
- Hwaseong, South Korea
- Product
- Onabotulinumtoxina
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Aug 13, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3012333115
- FDA shipment ID
- AEK-0699449-4/20002/1
Why FDA refused it
Misbranding502(o), 801(a)(3); MISBRANDING
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Misbranding502(o), 801(a)(3); MISBRANDING
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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: 118 (Misbranding) · 3280 (Misbranding) · 472 (Misbranding) · 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 AEK-0699449-4/20002/1 (or firm FEI 3012333115), refused Aug 13, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) · Hwaseong · drug product · refused as misbranding, unapproved new drug
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