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Procaps S.A. de C.V.

FDA import alert and refusal historySoyapango, El SalvadorFEI 3013263887

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Example subjectProcaps S.A. de C.V added to Import Alert 16-129 (red list)

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As of October 26, 2026, Procaps S.A. de C.V. is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between July 11, 2019 and September 24, 2025, most often for required label information not in english (NO ENGLISH).

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

Current status

Import alerts
Not listed
Last import refusal
Mecobalamin (vitamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Procaps S.A. de C.V.

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

2025

  1. Import refusal
    Refused, Mecobalamin (vitamin)UNAPPROVEDEntry AEK-7567983-5
    Source

2023

  1. Recall
    Recall (Class II), Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard boxPEG-40 not declared as an ingredient on the label
    Source

2019

  1. Import refusal
    Refused, Vitamin aNO ENGLISHEntry E84-0090361-1
    Source

Refusal charges, in plain English

  • NO ENGLISH1 refused line

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • 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 Procaps S.A. de C.V.

Is Procaps S.A. de C.V. on an FDA import alert?
No listing for Procaps S.A. de C.V. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the El Salvador page.
Has FDA refused shipments from Procaps S.A. de C.V.?
Yes. FDA refused 2 shipment lines from Procaps S.A. de C.V. between July 11, 2019 and September 24, 2025. The most recent, on September 24, 2025, was mecobalamin (vitamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Procaps S.A. de C.V.'s shipments?
The most frequent charges are NO ENGLISH (required label information not in english, 1 line) and UNAPPROVED (unapproved new drug, 1 line).
What is Procaps S.A. de C.V.'s FEI number?
Procaps S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3013263887.

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Example subjectProcaps S.A. de C.V 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.