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Botane Pharm

FDA import alert and refusal historyRio De Janeiro, BrazilFEI 3040898948

Recorded by FDA as BOTANE PHARM

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Example subjectBotane Phar added to Import Alert 16-129 (red list)

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As of October 25, 2026, Botane Pharm is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines on November 26, 2025, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Botane Pharm

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

2025

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7916575-7Show 2 lines
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7916575-7Source
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7916575-7Source
    Source

Refusal charges, in plain English

  • UNAPPROVED2 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.

Questions about Botane Pharm

Is Botane Pharm on an FDA import alert?
No listing for Botane Pharm appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Brazil page.
Has FDA refused shipments from Botane Pharm?
Yes. FDA refused 2 shipment lines from Botane Pharm on November 26, 2025. The most recent, on November 26, 2025, 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 Botane Pharm's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Botane Pharm's FEI number?
Botane Pharm's FDA Establishment Identifier (FEI) is 3040898948.

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Example subjectBotane Phar added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.