Dannex Ltd

5 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED4 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• DIETARYLBL1 refused line

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• FALSE1 refused line

  False or misleading labeling

  The labeling appeared to be false or misleading in some particular.

• HEALTH C1 refused line

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LABELING1 refused line

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

Questions about Dannex Ltd

Is Dannex Ltd on an FDA import alert?

No listing for Dannex Ltd appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Ghana page.

Has FDA refused shipments from Dannex Ltd?

Yes. FDA refused 5 shipment lines from Dannex Ltd between September 6, 2017 and January 2, 2026. The most recent, on January 2, 2026, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Dannex Ltd's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 4 lines) and DIETARYLBL (not identified as a dietary supplement, 1 line).

What is Dannex Ltd's FEI number?

Dannex Ltd's FDA Establishment Identifier (FEI) is 3011640723.