FDA import refusal: Daxxify (daxibotulinumtoxinA)-LANM (Vietnam)
FDA blocks import of DaxibotulinumtoxinA-Lanm from Vietnam.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated September 16, 2026, in the Aesthetic Injectables category.
An import refusal marks a shipment 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
- Recorded
- September 16, 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
Free weekly Brief
Get the changes that matter in plain English, every week — and be alerted when the rules move. No charge.
Members get a specific “what to do” wherever a change calls for one — in one daily email, for your states. See one unlocked → · Pricing →
The FDA record
- Firm
- COMEM NATURAL JSC
- Origin
- Ha Noi, Vietnam
- Product
- Daxibotulinumtoxina-Lanm
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Sep 16, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3044410908
- FDA shipment ID
- 1FX-2060356-0/20002/1B
Why FDA refused it
FDA does not publish plain-language definitions for this shipment’s charge codes (a drugs and biologic refusal) — the firm, product, and origin above carry the meaning.
FDA charge codes on this record: 9999978 (no public definition) · 9999979 (no public definition) · 9999980 (no public definition).
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID 1FX-2060356-0/20002/1B (or firm FEI 3044410908), refused Sep 16, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · COMEM NATURAL JSC · Ha Noi · drug product · refused entry by FDA
Related alerts
- FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Vietnam)
- FDA import refusal: Acid, Hyaluronic, Intraarticular (Sweden)
MedSpaRadar is regulatory monitoring and reference: it summarizes public laws, regulations and agency actions and links each to its source. It is not legal, medical, or compliance advice, and using it creates no attorney-client relationship. A summary can lag its source or leave out detail, and monitoring itself can be interrupted — so an absence of alerts means nothing reached you, not that nothing happened. Read the cited source, check its effective date, and confirm any change to your operations or clinical practice with qualified health-law counsel and your medical director.