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MONITORFEDAesthetic InjectablesJul 24, 2026

FDA import refusal: Botox (onabotulinumtoxinA) (Germany)

FDA refuses entry for OnabotulinumtoxinA from Germany.

What changed & why it matters

Med Spa Radar recorded an FDA import refusal at the federal level, dated July 24, 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
July 24, 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.

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
Merz Pharma Gmbh & Co. KGaA
Origin
Reinheim, Germany
Product
Onabotulinumtoxina
FDA classification
Human and Animal Therapeutic Biologic and Biosimilar Drugs
Refused
Jul 24, 2026
FDA district
Division of Southeast Imports
Firm FEI
3006999111
FDA shipment ID
AEK-0899170-4/50002/1

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(a) & (f)(1), 801(a)(3); MISBRANDING

    The article appears to be a drug which requires a prescription from your doctor.

  • 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) · 342 (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-0899170-4/50002/1 (or firm FEI 3006999111), refused Jul 24, 2026.

FDA Import Refusal · FDA Import Refusals database ↗FDA record · Merz Pharma Gmbh & Co. KGaA · Reinheim · drug product · refused as misbranding, unapproved new drug

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Monitoring, not legal advice.