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FDA import refusals

FDA import refusals: meal replacements from Mexico

FDA category: Dietary Conventional Foods and Meal Replacements · October 2016 to September 14, 2026

FDA refused 595 meal replacements shipment lines from Mexico between October 2016 and September 14, 2026, 18 of them in 2026; the most refused products were oral rehydration products and foods with supplemental nutrients added, most often for UNAPPROVED (unapproved new drug).

Data from FDA public records, last checked .

595
meal replacements lines refused since October 2016
18
refused so far in 2026
10
firms with the most records, listed below

Meal replacements refusals from Mexico by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.
Bar chart: refusal lines by 2016 to 2026. The same numbers are in the table.0501001502002016 (from October 1): 7 refusal lines’162017: 18 refusal lines’172018: 28 refusal lines’182019: 14 refusal lines’192020: 33 refusal lines’202021: 20 refusal lines’212022: 113 refusal lines’222023: 154 refusal lines154’232024: 110 refusal lines’242025: 80 refusal lines’252026 (year to date): 18 refusal lines18’26*
* 2026 is year to date, through September 14, 2026. FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)18
202580-27%
2024110-29%
2023154+36%
2022113+465%
202120-39%
202033+136%
201914-50%
201828+56%
201718
2016 (from Oct)7

Oral rehydration products refusals from Mexico

FDA refused 294 oral rehydration products lines from Mexico between October 2016 and September 14, 2026, 49% of the meal replacements lines.
Oral rehydration products product descriptions refused from Mexico
FDA product descriptionLinesShare of meal replacements
Oral rehydration products29449.4%

Recent oral rehydration products refusals

Recent Oral rehydration products refusals from Mexico
DateFirmProductCharges
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source

Foods with supplemental nutrients added refusals from Mexico

FDA refused 196 foods with supplemental nutrients added lines from Mexico between October 2016 and September 14, 2026, 33% of the meal replacements lines.
Foods with supplemental nutrients added product descriptions refused from Mexico
FDA product descriptionLinesShare of meal replacements
Foods with supplemental nutrients added, with or without artifical sweetners19632.9%

Recent foods with supplemental nutrients added refusals

Recent Foods with supplemental nutrients added refusals from Mexico
DateFirmProductCharges
Jr Ismerely LabsGuanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE COLCOLOR LBLGSource
Jr Ismerely LabsGuanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE COLCOLOR LBLGSource
Med Plants of Mexico AkDelegacion, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHDIETARYINGLABELING+1Source
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource

Dietary conventional foods refusals from Mexico

FDA refused 84 dietary conventional foods lines from Mexico between October 2016 and September 14, 2026, 14% of the meal replacements lines.
Dietary conventional foods product descriptions refused from Mexico
FDA product descriptionLinesShare of meal replacements
Dietary conventional foods, n.e.c.8414.1%

Other meal replacements products refused from Mexico

Products refused from Mexico in meal replacements
Product groupLinesShare
Medical foods132.2%
Foods with artificial sweetners but without supplemental nutrients40.7%
Meal replacements40.7%

Why FDA refused meal replacements from Mexico

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for meal replacements from Mexico
Charge codeMeaningLinesShare
UNAPPROVEDUnapproved new drug38026%
NO ENGLISHRequired label information not in English29720%
NUTRIT LBLNutrition information missing from label24117%
INCONSPICURequired information not conspicuous1309%
FALSEFalse or misleading labeling977%
LIST INGREIngredients not listed826%
UNSAFE ADDFood additive unsafe under section 409745%
UNSAFE COLColor additive unsafe under section 721574%
LACKS N/CNet quantity statement missing473%
COLOR LBLGArtificial coloring not declared463%

Import alerts for meal replacements that list Mexico firms

Import alerts for meal replacements listing firms in Mexico
AlertCoversRedGreen
41-03Adulterated and Misbranded Medical Foods1

Mexico meal replacements firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.
Mexico meal replacements firms with the most FDA records
FirmCityFDA records
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga265
Sinergia SadelcoHeroica Nogales31
Healthy People Labs S de RL de CVIrapuato28
Healthy People S de R.L. de CVIrapuato20
Corporativo Serysi, S. De R.L. De C.V.Zapopan19
Natural ProvidaGuadalajara16
Pisa Agropecuaria, S.A. de C.V.Guadalajara13
D.M. Mexicana SA de CVSan Nicolas De Los Garza13
Laboratorios de Fuerza de la Salud S.A de CVDistrito Federal11
Tonic Life S de RLIrapuato10

Latest meal replacements refusals from Mexico

Latest FDA meal replacements refusals from Mexico
DateFirmProductCharges
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsLIST INGREINCONSPICUFALSE+4Source
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MexicoOral rehydration productsINCONSPICUSource
Jr Ismerely LabsGuanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE COLCOLOR LBLGSource
Jr Ismerely LabsGuanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE COLCOLOR LBLGSource
Med Plants of Mexico AkDelegacion, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHDIETARYINGLABELING+1Source
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
Ismerely SA de CVIrapuato, Guanajuato, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
Broncolin, S.A. de C.V.Ciudad De Mexico, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDSource
D.M. Mexicana SA de CVSan Nicolas De Los Garza, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE ADDSource
D.M. Mexicana SA de CVSan Nicolas De Los Garza, MexicoFoods with supplemental nutrients added, with or without artifical sweetnersUNSAFE ADDSource

Questions about meal replacements refusals from Mexico

How many meal replacements shipments from Mexico did FDA refuse in 2026?
FDA refused 18 shipment lines of meal replacements from Mexico in 2026 through September 14, 2026, compared with 80 in 2025.
Why does FDA refuse meal replacements from Mexico?
FDA records a charge code on every refused shipment line. For meal replacements from Mexico the most frequent are UNAPPROVED (unapproved new drug, 380 lines), NO ENGLISH (required label information not in English, 297 lines) and NUTRIT LBL (nutrition information missing from label, 241 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover meal replacements from Mexico?
As of October 26, 2026, the FDA import alerts for this category that list Mexico firms are Import Alert 41-03 (1 firm). General food alerts numbered 99-xx can list Mexico firms too; see the country page.

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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.