MONITORFEDAesthetic InjectablesJul 21, 2026

FDA import refusal: Lidocaine (Belgium)

FDA refuses entry of lidocaine from Belgium—check your suppliers!

What changed & why it matters

Med Spa Radar recorded an FDA import refusal at the federal level, dated July 21, 2026, in the Aesthetic Injectables category, naming LIDOCAINE.

An import refusal marks a shipment of LIDOCAINE 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
LIDOCAINE
Recorded
July 21, 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: Official Action Indicated

This firm’s most recent FDA inspection was classified Official Action Indicated (OAI) — FDA’s most serious outcome, signaling significant violations.

Source: FDA Data Dashboard inspection classifications (most recent, by firm FEI).

What to do

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The FDA record

Firm
Laboratoria Qualiphar NV
Origin
Bornem, Belgium
Product
Lidocaine
FDA classification
Human Drugs
Refused
Jul 21, 2026
FDA district
Division of Northern Border Imports
Firm FEI
1000627334
FDA shipment ID
231-7818618-2/10002/1

Why FDA refused it

  • Adulteration501(a)(2)(B), 801(a)(3); ADULTERATION

    The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

FDA charge codes on this record: 27 (Adulteration). 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 231-7818618-2/10002/1 (or firm FEI 1000627334), refused Jul 21, 2026.

FDA Import Refusal · FDA Import Refusals databaseFDA record · Laboratoria Qualiphar NV · Bornem · drug product · refused as adulteration

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Monitoring, not legal advice.