FDA import refusals
FDA import refusals: meal replacements from Mexico
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
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 18 | |
| 2025 | 80 | -27% |
| 2024 | 110 | -29% |
| 2023 | 154 | +36% |
| 2022 | 113 | +465% |
| 2021 | 20 | -39% |
| 2020 | 33 | +136% |
| 2019 | 14 | -50% |
| 2018 | 28 | +56% |
| 2017 | 18 | |
| 2016 (from Oct) | 7 |
Oral rehydration products refusals from Mexico
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Oral rehydration products | 294 | 49.4% |
Recent oral rehydration products refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source |
Foods with supplemental nutrients added refusals from Mexico
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Foods with supplemental nutrients added, with or without artifical sweetners | 196 | 32.9% |
Recent foods with supplemental nutrients added refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Jr Ismerely LabsGuanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE COLCOLOR LBLG | Source | |
| Jr Ismerely LabsGuanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE COLCOLOR LBLG | Source | |
| Med Plants of Mexico AkDelegacion, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISHDIETARYINGLABELING+1 | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source |
Dietary conventional foods refusals from Mexico
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Dietary conventional foods, n.e.c. | 84 | 14.1% |
Other meal replacements products refused from Mexico
| Product group | Lines | Share |
|---|---|---|
| Medical foods | 13 | 2.2% |
| Foods with artificial sweetners but without supplemental nutrients | 4 | 0.7% |
| Meal replacements | 4 | 0.7% |
Why FDA refused meal replacements from Mexico
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 380 | 26% |
| NO ENGLISH | Required label information not in English | 297 | 20% |
| NUTRIT LBL | Nutrition information missing from label | 241 | 17% |
| INCONSPICU | Required information not conspicuous | 130 | 9% |
| FALSE | False or misleading labeling | 97 | 7% |
| LIST INGRE | Ingredients not listed | 82 | 6% |
| UNSAFE ADD | Food additive unsafe under section 409 | 74 | 5% |
| UNSAFE COL | Color additive unsafe under section 721 | 57 | 4% |
| LACKS N/C | Net quantity statement missing | 47 | 3% |
| COLOR LBLG | Artificial coloring not declared | 46 | 3% |
Import alerts for meal replacements that list Mexico firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 41-03 | Adulterated and Misbranded Medical Foods | 1 |
Mexico meal replacements firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga | 265 |
| Sinergia Sadelco | Heroica Nogales | 31 |
| Healthy People Labs S de RL de CV | Irapuato | 28 |
| Healthy People S de R.L. de CV | Irapuato | 20 |
| Corporativo Serysi, S. De R.L. De C.V. | Zapopan | 19 |
| Natural Provida | Guadalajara | 16 |
| Pisa Agropecuaria, S.A. de C.V. | Guadalajara | 13 |
| D.M. Mexicana SA de CV | San Nicolas De Los Garza | 13 |
| Laboratorios de Fuerza de la Salud S.A de CV | Distrito Federal | 11 |
| Tonic Life S de RL | Irapuato | 10 |
Latest meal replacements refusals from Mexico
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | LIST INGREINCONSPICUFALSE+4 | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, Mexico | Oral rehydration products | INCONSPICU | Source | |
| Jr Ismerely LabsGuanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE COLCOLOR LBLG | Source | |
| Jr Ismerely LabsGuanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE COLCOLOR LBLG | Source | |
| Med Plants of Mexico AkDelegacion, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISHDIETARYINGLABELING+1 | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| Ismerely SA de CVIrapuato, Guanajuato, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| Broncolin, S.A. de C.V.Ciudad De Mexico, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNAPPROVED | Source | |
| D.M. Mexicana SA de CVSan Nicolas De Los Garza, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE ADD | Source | |
| D.M. Mexicana SA de CVSan Nicolas De Los Garza, Mexico | Foods with supplemental nutrients added, with or without artifical sweetners | UNSAFE ADD | Source |
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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