What does RXLABEL mean on an FDA refusal?

RXLABEL is the refusal charge “The labeling fails to bear, at a minimum, the symbol "RX Only".”. FDA's official statement for the charge reads: “The labeling fails to bear, at a minimum, the symbol "RX Only".”

What law does RXLABEL cite?

FDA's refusal charge table cites sections 503(b)(4)(A) and 801(a)(3) of the FD&C Act (misbranding) for RXLABEL, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most RXLABEL refusals?

As of October 26, 2026, the countries with the most RXLABEL refusal lines are Guatemala (2) and India (1). The full list with links is in the table on this page.

Is there an FDA import alert for RXLABEL?

SupplierRadar found no food import alert whose charge section names RXLABEL. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

RXLABEL is the FDA import refusal charge for the labeling fails to bear, at a minimum, the symbol "RX Only".; it cites sections 503(b)(4)(A) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 3 refused shipment lines from 2 countries between October 2016 and October 2, 2026, most often for dietary supplements from Guatemala.

Data from FDA public records, last checked October 26, 2026.

3
refused shipment lines carry this charge: 2
countries of origin: 0
import alerts name this charge

What RXLABEL means

SupplierRadar has not written a plain-English version of RXLABEL yet. FDA's own statement is quoted below.

FD&C Act section: 503(b)(4)(A)801(a)(3)
Classification: misbranding

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

The labeling fails to bear, at a minimum, the symbol "RX Only".

RXLABEL · 503(b)(4)(A), 801(a)(3); MISBRANDINGFDA reference table (CSV)

Countries with the most RXLABEL refusals

Shipment lines carrying RXLABEL, by country of origin.

RXLABEL refusal lines by country
Country	Lines	Share of RXLABEL
Guatemala	2	67%
India	1	33%

Product categories with the most RXLABEL refusals

RXLABEL refusal lines by product category
Category	Lines	Share of RXLABEL
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	3	100%

Latest RXLABEL refusals

The 3 most recent refused lines, through October 2, 2026, each with its FDA source.

Latest FDA refusals carrying RXLABEL
Date	Firm	Product	Charges
Oct 2, 2026	American VitalabNa, Guatemala	Vitamin b12 (cyanocobalamin)	RXLABEL LABELING	Source
Oct 2, 2026	Piersan Centroamericana, S.A.Unknown, Guatemala	Vitamin b12 (cyanocobalamin)	LACKS FIRM RXLABEL LABELING	Source
Oct 11, 2018	Emcure Pharmaceuticals LimitedAhmedabad, India	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	DIRECTIONS LIST INGRE NO ENGLISH+3	Source

Questions about RXLABEL

What does RXLABEL mean on an FDA refusal?: RXLABEL is the refusal charge “The labeling fails to bear, at a minimum, the symbol "RX Only".”. FDA's official statement for the charge reads: “The labeling fails to bear, at a minimum, the symbol "RX Only".”
What law does RXLABEL cite?: FDA's refusal charge table cites sections 503(b)(4)(A) and 801(a)(3) of the FD&C Act (misbranding) for RXLABEL, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most RXLABEL refusals?: As of October 26, 2026, the countries with the most RXLABEL refusal lines are Guatemala (2) and India (1). The full list with links is in the table on this page.
Is there an FDA import alert for RXLABEL?: SupplierRadar found no food import alert whose charge section names RXLABEL. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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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.