FDA import refusal: Acid, Hyaluronic, Intraarticular (Ireland)
FDA refused hyaluronic acid import from Ireland; confirm violation details.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 20, 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
- August 20, 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
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The FDA record
- Firm
- MYLAN INTERNATIONAL
- Origin
- Galway, Ireland
- Product
- Acid, Hyaluronic, Intraarticular
- FDA classification
- Orthopedics Medical Devices
- Refused
- Aug 20, 2026
- FDA district
- Division of Northeast Imports
- Firm FEI
- 3046435039
- FDA shipment ID
- SCS-2589595-2/20002/1
Why FDA refused it
Misbranding502(o), 801(a)(3); MISBRANDING
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FDA charge codes on this record: 341 (Misbranding). 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-2589595-2/20002/1 (or firm FEI 3046435039), refused Aug 20, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · MYLAN INTERNATIONAL · Galway · medical device · refused as misbranding
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