| 2026-06-17 | ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED. | Refresqueria Estrella Inc. | Undeclared FD&C Red 40 | Class III |
| 2026-01-14 | Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022 | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2026-01-14 | Tempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127 Tempting Crackers, Rovira, 12 packets (Net Wt. 1.0 oz (30 g) bag) per box, 12/ 1.0 oz packets box, 6/ 12-1oz box per case. UPC 072981003127 | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2026-01-14 | Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374 | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2026-01-14 | Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064 100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035 100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073 | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2026-01-14 | Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022 | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2026-01-14 | Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343 Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case. | Rovira Biscuit Corporation | Undeclared colors FD&C Yellow #6, and FD&C Red 40 | Class II |
| 2024-10-02 | Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz. | Avole, Inc. | Allergen not listed in the Contains statement: Fish | Class II |
| 2024-05-15 | Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case | Tradewind Foods de Puerto Rico Inc. | During an FDA Inspection it was discovered swollen and leaking cans. | Class II |
| 2024-05-08 | Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900313. | Reposteria Artesanal Laura | Failure to declare FD&C Red #40, Red #3,Yellow #5, Yellow #6, Blue #1 and Blue #2 | Class II |
| 2024-03-20 | Vitony Bakery, Bizcocho de Queso y Guayaba (cheese-guava cake), PESO NETO 14oz (397g) (12 (14 oz) packages per case) | Vitony Bakery, Inc. | Undeclared allergens FD&C Yellow #5, Yellow #6 | Class II |
| 2024-03-20 | Vitony Bakery, Bizcocho de Queso (cheesecake), PESO NETO 14oz (397g) (12 (14 oz) packages per case) | Vitony Bakery, Inc. | Undeclared allergens FD&C Yellow #5, Yellow #6 | Class II |
| 2024-01-17 | Brand Name: SUPREX Plant Based Nutrition. Product Name: Carb & Sugar Block. Product Size: 120 Vegetable Cellulose Capsules per bottle. Container description: White Plastic Bottle 300CC with white cap sealed with clear plastic Total Package size: Master Case with 81 Bottles containing 120 capsules each one. Lot no. 2633, Exp. 07/25 Manufactured in the US | Vita 360, LLC | FDA lab analysis of product sampled revealed Chromium content was determined subpotent as 16 mcg/serving or 16% of declared. | Class III |
| 2023-11-29 | ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104. | ActiPharma, Inc. | FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim. | Class III |
| 2023-05-10 | GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case. | Novis PR, LLC dba Kramer Novis | Bloated Protein Bottle | Class II |
| 2023-05-10 | PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case | Novis PR, LLC dba Kramer Novis | Bloated Protein Bottle | Class II |
| 2023-05-10 | PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case. | Novis PR, LLC dba Kramer Novis | Bloated Protein Bottle | Class II |
| 2022-10-19 | G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novis | Novis PR, LLC dba Kramer Novis | Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present. | Class III |
| 2022-06-01 | Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelunie, Produced in France | Able Sales Company, Inc. | Traces of 2-chloro-ethanol (2-CE) in wheat gluten. | Class III |
| 2021-12-29 | Hacienda Las Glorias Premium, Bebida de Parcha (Passion Fruit Drink) 16 Oz. (480 ML) | San Mar Manufacturing Corporation | Undeclared Yellow #5 | Class II |
| 2021-12-01 | Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans per case of 46 oz each | Empresas La Famosa, Inc. | Discovered swollen cans | Class III |
| 2021-10-06 | Crunchy Cones, Chocolate, 12, NET WT 40oz (113g) | Borinquen Cones of Puerto Rico, Inc. | Undeclared sulfites in product label. | Class III |
| 2021-10-06 | Crunchy Cones, Mix Choco-Vanilla, 12, NET WT 40oz (113g) | Borinquen Cones of Puerto Rico, Inc. | Undeclared sulfites in product label. | Class III |
| 2021-06-23 | BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801 | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-06-23 | BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples) | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-05-26 | BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples) | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-05-26 | BTREX PLUS, Dietary Supplement 100 Caplets | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-05-19 | BTREX PLUS, Dietary Supplement 100 Caplets | Lopez Gonzalez Santana Corporation | cGMP Deviation: Presence of damaged tablets | Class III |
| 2021-04-14 | Crimson Snapper Fillet, Natural Cut CO Treated, Net WT 10 LBS, Size 10/12 oz | Sea World, LLC | Fish decomposition. | Class III |
| 2019-12-18 | Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-11 | Onion Minced: 16-40 Mesh, Net Weight: 24/kg/52.91lbs, Manufacturing Date: May, 2019, Country of Origin: China, Manufactured for GH Imports Inc. | GH IMPORTS, INC | Customer notified firm of a metal filament found in a package of minced onion product. | Class II |
| 2019-11-13 | La Samaritana Tortillas (Harina de Trigo) 8/12-12" Reg Rojo | Productos La Samaritana, Inc. | Failure to declare FD&C Red #40 | Class III |
| 2019-11-13 | Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate | Productos La Samaritana, Inc. | Failure to declare FD&C Red #40 | Class III |
| 2019-09-25 | Coconut Macaroons "Besitos de Coco" packaged in 6 oz. clamshell containers with brand name La Orocovena Biscuit. | La Orocovena Biscuit de PR, Inc. | Coconut Macaroons contain undeclared FD&C Yellow # 5 and FD&C Yellow #6. | Class II |
| 2019-09-11 | Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G) | Vitony Bakery, Inc. | Failure to declare Soy, FD&C Yellow #5 and #6 and lack of Keep Refrigerated labeling. | Class II |
| 2019-09-11 | Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G) | Vitony Bakery, Inc. | Failure to declare Sodium Metabisulfite. | Class II |
| 2019-09-11 | Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G) | Vitony Bakery, Inc. | Failure to declare FD&C Yellow #5 and FD&C Yellow #6. | Class II |
| 2019-03-13 | Gasc¿ Golden Egg Yellow Shade Food Color, Contains: 32 fl. oz. (946 mL) | Gasco Industrial, Corp. | Failure to declare Yellow #5 and potassium sorbate | Class II |
| 2019-03-13 | Gasc¿ Tomato Red Food Color, Net Contents: 5 gal (640 fl. oz) | Gasco Industrial, Corp. | Failure to declare Yellow #6 | Class II |
| 2018-12-05 | Oreo Limber. 6 dozen per case of 6.5 oz each | La Casa del Limber, Inc. | The product label failed to declare wheat as one of its ingredients. | Class II |
| 2018-11-28 | Super Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603 | Elaboraciones Felo, Inc. | Products failed to declare allergens: Soy and Sulfites | Class I |
| 2018-11-28 | Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603 | Elaboraciones Felo, Inc. | Products failed to declare allergens: Wheat and Soy | Class I |
| 2018-11-28 | Square Shell for Turnovers, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603 | Elaboraciones Felo, Inc. | Products failed to declare allergens: Wheat, Soy, and Red No. 40 | Class I |
| 2018-11-28 | White Round Shell for Turnovers, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603 | Elaboraciones Felo, Inc. | Products failed to declare allergens: Wheat and Soy | Class I |
| 2018-11-14 | Orange plus Citrus Beverage from Concentrate | Campofresco Corp. | The product may be contaminated with a sanitizing solution | Class II |
| 2018-03-14 | BELCA Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Distribuido por: Mister Price Inc. San Juan, P.R. 00936 | Gasco Industrial, Corp. | Undeclared allergen: Wheat | Class II |
| 2018-03-14 | NuChef Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Packed for Northwestern Selecta | Gasco Industrial, Corp. | Undeclared allergen: Wheat | Class II |
| 2018-02-14 | Pound Cake NET WT 4OZ and 12OZ. | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, and milk. | Class I |
| 2018-02-14 | Mallorca Queso NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: soy | Class I |
| 2018-02-14 | Bizcocho de Vainilla con Queso [Vanilla Cake with Cheese] NET WT 4OZ and 12OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, milk, Yellow # 5, and Yellow # 6. | Class I |
| 2018-02-14 | TITAN, 24 rellenos de papas, (potato puffs), Net WT 6.75 LB (pounds) | Empresas Barsan, Inc. | Finished product label does not declare Sodium Bisulfite as an ingredient. | Class II |
| 2018-02-14 | Pan [bread] NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Undeclared allergens: soy. | Class I |
| 2018-02-14 | Bizcocho Zanahoria [Carrot Cake] NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, eggs, and milk. | Class I |
| 2018-02-14 | Bizcocho de Vainilla con Guava [Vanilla Cake with Guava] NET WT 4OZ and 12OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, milk, Red # 40, and potassium sorbate. | Class I |
| 2018-02-14 | Bizcocho Maiz [Corn Cake] NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat and milk. | Class I |
| 2018-02-14 | TITAN, 6 rellenos, Potato Puffs with Meat Flavor, Net Weight 26.4 oz (748g) | Empresas Barsan, Inc. | Finished product label does not declare Sodium Bisulfite as an ingredient. | Class II |
| 2018-02-14 | Pan con pasas [Bread with raisins] NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, and egg. | Class I |