Botanikur Inc.

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

Refusal charges, in plain English

• UNAPPROVED5 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.

• DIRSEXMPT4 refused lines

  DIRSEXMPT

• MFR INSAN3 refused lines

  Insanitary manufacturing, processing or packing

  The product appeared to have been manufactured, processed, or packed under insanitary conditions, which is a ground for refusal under section 801(a)(1) of the FD&C Act.

• LABELING2 refused lines

  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.

• FILTHY1 refused line

  Filthy, putrid or decomposed substance

  The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

• NO PROCESS1 refused line

  No scheduled process filed

  The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.

• NUTRIT LBL1 refused line

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• PB-FOOD1 refused line

  PB-FOOD

Questions about Botanikur Inc.

Is Botanikur Inc. on an FDA import alert?

No listing for Botanikur Inc. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Canada page.

Has FDA refused shipments from Botanikur Inc.?

Yes. FDA refused 11 shipment lines from Botanikur Inc. between October 5, 2020 and May 22, 2025. The most recent, on May 22, 2025, was herbals & botanicals (not teas), n.e.c., charged as DIRSEXMPT (dirsexmpt).

Why did FDA refuse Botanikur Inc.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and DIRSEXMPT (dirsexmpt, 4 lines).

What is Botanikur Inc.'s FEI number?

Botanikur Inc.'s FDA Establishment Identifier (FEI) is 3014273103.