FDA import refusal: Solution, Sodium Hyaluronate (South Korea)

What changed & why it matters

Med Spa Radar recorded an FDA import refusal at the federal level, dated August 3, 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 3, 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.

What to do

The FDA record

Firm

Dongkook Pharmaceutical Co., Ltd.

Origin

Seoul, South Korea

Product

Solution, Sodium Hyaluronate

FDA classification

Gastroenterology and Urology Medical Devices

Refused

Aug 3, 2026

FDA district

Division of Southeast Imports

Firm FEI

3004967587

FDA shipment ID

AEK-0699455-1/10002/1B

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).

• Adulteration501(f)(1)(B), 801(a)(3); ADULTERATION

  The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

• Misbranding502(c); 801(a)(3);Misbranding

  Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

• 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.

• Misbranding801(a)(3); 502(o) Misbranding

  The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

FDA charge codes on this record: 118 (Misbranding) · 237 (Adulteration) · 3260 (Misbranding) · 3280 (Misbranding) · 508 (Misbranding). Definitions via the FDA Refusal Charges Reference.