FDA import refusal: Daxxify (daxibotulinumtoxinA)-LANM
FDA refuses entry for DAXIBOTULINUMTOXINA-LANM; avoid unverified sources.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated July 8, 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
- July 8, 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
- Revance Therapeutics, Inc
- Origin
- Newark, United States
- Product
- Daxibotulinumtoxina-Lanm
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Jul 8, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3007772056
- FDA shipment ID
- SCS-4140684-1/20002/1A
Why FDA refused it
AGR RX801(d)(1),(2); IMPORTATION RESTRICTED
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
FDA charge codes on this record: 179 (AGR RX). 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 SCS-4140684-1/20002/1A (or firm FEI 3007772056), refused Jul 8, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Revance Therapeutics, Inc · Newark · drug product · refused entry by FDA
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