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Square Pharmaceuticals PLC

FDA import alert and refusal historyGazipur, BangladeshFEI 3003670128

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Example subjectSquare Pharmaceuticals PL added to Import Alert 16-129 (red list)

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As of October 26, 2026, Square Pharmaceuticals PLC is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on November 10, 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
Ashwagandha (herbal & botanicals, not teas) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Square Pharmaceuticals PLC

1 record, newest first. Each line links to the FDA page it came from.

2025

  1. Import refusal
    Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-7845871-6
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    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 Square Pharmaceuticals PLC

Is Square Pharmaceuticals PLC on an FDA import alert?
No listing for Square Pharmaceuticals PLC appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Bangladesh page.
Has FDA refused shipments from Square Pharmaceuticals PLC?
Yes. FDA refused 1 shipment line from Square Pharmaceuticals PLC on November 10, 2025. The most recent, on November 10, 2025, was ashwagandha (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Square Pharmaceuticals PLC's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
What is Square Pharmaceuticals PLC's FEI number?
Square Pharmaceuticals PLC's FDA Establishment Identifier (FEI) is 3003670128.

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Example subjectSquare Pharmaceuticals PL 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.