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Glaxo SmithKline Ltd

FDA import alert and refusal historyNabha, IndiaFEI 3010099091

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Example subjectGlaxo SmithKline Lt added to Import Alert 16-129 (red list)

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As of October 26, 2026, Glaxo SmithKline Ltd (Nabha, India) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for mother's horlicks vanilla drink mix, published by FDA on February 25, 2016, is also listed on Import Alert 99-39 (red list), and has 10 FDA import refusals recorded since October 2016.

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

Current status

Last import refusal
Beverage base not mentioned elsewhere, n.e.c. · LIST INGRE
Last warning letter
None found
Last inspection
None on record

Every FDA record for Glaxo SmithKline Ltd

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

2019

  1. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.LIST INGRELACKS N/CUSUAL NAMENUTRIT LBLEntry KM6-3530738-2
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Beverage base not mentioned elsewhere, n.e.c.LABELINGEntry WD8-0062464-1Show 2 lines
    • Refused, Beverage base not mentioned elsewhere, n.e.c.LABELINGEntry WD8-0062464-1Source
    • Refused, Beverage base not mentioned elsewhere, n.e.c.LABELINGEntry WD8-0062464-1Source
    Source
  3. Import refusal
    Refused, 2 lines in one entry: Beverage base not mentioned elsewhere, n.e.c.NUTRIT LBLEntry WD8-0049123-1Show 2 lines
    • Refused, Beverage base not mentioned elsewhere, n.e.c.NUTRIT LBLEntry WD8-0049123-1Source
    • Refused, Beverage base not mentioned elsewhere, n.e.c.NUTRIT LBLEntry WD8-0049123-1Source
    Source

2018

  1. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.LIST INGREUSUAL NAMENUTRIT LBLEntry KM6-3512828-3
    Source

2016

  1. Import refusal
    Refused, 2 lines in one entry: Beverage base not mentioned elsewhere, n.e.c.LIST INGRENUTRIT LBLEntry KM6-0150873-2Show 2 lines
    Source
  2. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.LIST INGREINCONSPICUHEALTH CEntry KM6-0149025-3
    Source
  3. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.INCONSPICUHEALTH CEntry KM6-0149025-3
    Source
  4. Import alert listing
    Listed on Import Alert 45-02red listMother's Horlicks Vanilla Drink Mix
    Source

2015

  1. Import alert listing
    Listed on Import Alert 99-39red listHorlicks Drinks; Boost Drink Powder
    Source

Refusal charges, in plain English

  • NUTRIT LBL6 refused lines

    Nutrition information missing from label

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

  • LIST INGRE5 refused lines

    Ingredients not listed

    The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

  • HEALTH C2 refused lines

    Unauthorized nutrient content or health claim

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

  • INCONSPICU2 refused lines

    Required information not conspicuous

    Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

  • 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.

  • USUAL NAME2 refused lines

    Common or usual name missing

    The label appeared not to show the common or usual name of the food.

  • LACKS N/C1 refused line

    Net quantity statement missing

    The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

Questions about Glaxo SmithKline Ltd

Is Glaxo SmithKline Ltd on an FDA import alert?
Yes. As of October 26, 2026, Glaxo SmithKline Ltd is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for mother's horlicks vanilla drink mix; FDA published the listing on February 25, 2016.
Has FDA refused shipments from Glaxo SmithKline Ltd?
Yes. FDA refused 10 shipment lines from Glaxo SmithKline Ltd between November 4, 2016 and December 11, 2019. The most recent, on December 11, 2019, was beverage base not mentioned elsewhere, n.e.c., charged as LIST INGRE (ingredients not listed).
Why did FDA refuse Glaxo SmithKline Ltd's shipments?
The most frequent charges are NUTRIT LBL (nutrition information missing from label, 6 lines) and LIST INGRE (ingredients not listed, 5 lines).
What is Glaxo SmithKline Ltd's FEI number?
Glaxo SmithKline Ltd's FDA Establishment Identifier (FEI) is 3010099091.
Can shipments from Glaxo SmithKline Ltd still enter the U.S.?
Shipments of mother's horlicks vanilla drink mix from Glaxo SmithKline Ltd can be detained without physical examination under Import Alert 45-02; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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Example subjectGlaxo SmithKline Lt 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.