Undeclared ingredient recalls
Federal recalls citing undeclared ingredients. Mislabeling that puts allergic and sensitive consumers at risk.
- Past 12 months
- 84
- Past 90 days
- 17
- Past 30 days
- 10
- Past 7 days
- 8
Recall volume — past 12 months
per monthSeverity class
past 12 monthsWhere it shows up
top product categories- Allergen69
- Food62
- Drug22
- Packaged Food19
- Supplement13
- Baby3
- 2026-02-18FDA-FoodKPCM New YorkClass IIStop using Preema food color powders
Preema brand Bright Red and Orange Food Colour Powders contain carmoisine, a banned food dye, and undeclared FD&C Yellow 5 and FD&C Red 40. These undeclared dyes may cause allergic reactions in sensitive individuals and can affect attention in children. The products were distributed in New York and Massachusetts.
- 2026-02-11FDA-FoodPrima FoodsClass IIIStop using BarbaCuban Cubama White Truffle Sauce
BarbaCuban Cubama White Truffle Sauce contains quinine that was not listed on the label. Quinine can cause serious health problems in some people, especially those taking certain medications or with specific medical conditions. The affected product was distributed in Florida with lot code #233/24 and a best-by date of 02/2026.
- 2026-02-11FDA-FoodPrima FoodsClass IIIStop using BarbaCuban 455 Everything Sauce
BarbaCuban 455 Everything Sauce (Original) contains quinine that is not listed on the label. Quinine can cause serious health problems in some people, especially those taking certain medications or with specific medical conditions. The sauce was distributed in Florida in 12 oz bottles and larger containers.
- 2026-02-11FDA-DrugGreen LumberClass IStop using Green Lumber Natural Fuel For Men
Green Lumber Natural Fuel For Men capsules were sold as a supplement but contain tadalafil, a prescription medication approved only for treating erectile dysfunction and certain heart conditions. The product was marketed and sold without FDA approval and without listing tadalafil on the label. Tadalafil can cause serious side effects, especially in people taking certain other medications or with certain health conditions.
- 2026-01-28FDA-FoodLily's Bakery FactoryClass IICheck Lily's Bakery Cuban Crackers for allergen warning
Lily's Bakery Factory Cuban Crackers (8 oz, UPC 5700300060, expiration 05/01/2026) contain food dyes—FD&C yellow #5, FD&C yellow #6, and FD&C red 40—that are not listed on the package label. These dyes can trigger allergic reactions in people with sensitivity to artificial food colorings. The product was distributed only in Florida.
- 2026-01-28FDA-FoodCatao MarketClass IIStop eating Catao Market Mini Gaceniga loaf cake
Catao Market LLC is recalling Mini Gaceniga Authentic Cuban Loaf Cake with raisins because the product contains FD&C Yellow #5, a food coloring that is not listed on the label. People with allergies or sensitivities to this dye may have a reaction if they consume the product.
- 2026-01-28FDA-FoodCatao MarketClass IIStop eating Gaceniga Cuban Loaf Cake Raisins
Gaceniga Authentic Cuban Loaf Cake Raisins contain an undeclared food coloring (FD&C Yellow #5) that is not listed on the label. This poses a risk to people with sensitivity or allergies to this dye. The affected product was distributed in Florida and has Best By dates between December 18, 2025 and March 18, 2026.
- 2026-01-28FDA-FoodCatao MarketClass IICheck Gacenéiga Cuban Loaf Cake for undeclared dye
Gacenéiga Authentic Cuban Loaf Cake Classic contains FD&C Yellow #5 food coloring that is not listed on the package label. This undeclared ingredient may pose a risk to people with sensitivities or allergies to this dye. The affected product was sold in Florida with Best By dates between December 18, 2025 and March 18, 2026.
- 2026-01-28FDA-DrugZydusClass IIStop using Zydus Icosapent Ethyl capsules
Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.
- 2026-01-14FDA-FoodRoviraClass IICheck Tita Crackers Rovira for undeclared dyes
Rovira Biscuit Corporation is recalling Tita Crackers in multiple package sizes because they contain food dyes (FD&C Yellow #6 and FD&C Red 40) that are not listed on the label. These dyes can be a serious concern for people with allergies or sensitivities to artificial colors. No injuries have been reported.
- 2026-01-14FDA-FoodRoviraClass IIVanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
Undeclared colors FD&C Yellow #6, and FD&C Red 40
- 2026-01-14FDA-FoodRoviraClass IIStop eating Rovira Tempting Crackers
Rovira Tempting Crackers contain two food colorings—FD&C Yellow #6 and FD&C Red 40—that are not listed on the package label. These dyes can cause allergic reactions in people sensitive to them. No injuries have been reported.
- 2026-01-14FDA-FoodRoviraClass IIDon't eat Rovira 100to en boca crackers
Rovira snack crackers sold in 1.5 oz and 7 oz packages contain two food dyes—FD&C Yellow #6 and FD&C Red 40—that are not listed on the label. People with allergies or sensitivities to these dyes could have a reaction if they consume the product without knowing the dyes are present.
- 2025-12-31FDA-FoodA New Life HerbsClass IIStop using A New Life Herbs Pain Away supplement
A New Life Herbs' Pain Away herbal supplement contains labeling that makes drug claims (like "analgesic" and "anti-inflammatory") without FDA approval. The product also lacks a required Supplement Facts label, making it misbranded. About 275 bottles were distributed across 13 states.
- 2025-12-31FDA-FoodA New Life HerbsClass IIStop using A New Life Herbs Chaga Mushroom supplement
A New Life Herbs Chaga Mushroom herbal supplement is being recalled because the label makes unapproved health claims (such as anti-cancer properties) and is missing required supplement information. The product does not meet FDA labeling standards for dietary supplements.
- 2025-12-17FDA-FoodGimme Coffee, Inc.Class IIStop using Gimme Coffee Decaf de Agua pods
Gimme Coffee decaf coffee pods labeled as "Decaf de Agua" were packaged with caffeinated "Deep Disco" pods instead. The mislabeled pods contain caffeine that is not declared on the outer packaging, which may be a concern for people avoiding caffeine. This affects 252 boxes sold in ten states with best-by dates of 09-30-2025 and 10-15-2025.
- 2025-12-17FDA-FoodKosher FirstClass IIIShloimy's Heimishe Matjes Herring packaged in 7oz plastic container
Undeclared FD&C Red #40
- 2025-12-10FDA-DrugBreckenridgeClass IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10FDA-DrugGlenmarkClass IIIBisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- 2025-10-29FDA-FoodTwin MarquisClass ITwin Marquis brand THICK SHANGHAI STYLE PLAIN NOODLE; NET WT 16 OZ; Ingredients: Bleached Wheat Flour, Water, Corn Starch, Salt, Sodium Benzoate (For Freshness); Contains: Wheat.; Produced on machinery that uses eggs; Manufactured by: Twin Marquis Inc. Brooklyn, NY 11206; UPC 7 60941 10301 6
Product contains undeclared egg, FD&C Yellow 5, and FD&C Yellow 6.
- 2025-10-15FDA-FoodEden's ElixirsClass IILifted Made Mint flavored tablets 20mg 7OH/550mg Tablet- Lifted Made-Mint, Chewable tablet, no shelf-life. Dosage: 2 doses per tablet. Shipping or unit package: 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.
Undeclared Yellow #5
- 2025-10-15FDA-FoodEden's ElixirsClass IILifted Made-Lemon, Chewable tablet. 20mg 7OH/550mg Tablet-no shelf-life. Dosage: 2 doses per tablet. Route of administration: oral. Shipping or unit package 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.
Undeclared Yellow #5
- 2025-10-08FDA-FoodGina Marie BakeryClass IIIToasted Cherry Biscotti
Contains undeclared Red 40
- 2025-10-08FDA-FoodGina Marie BakeryClass IIItalian Sesame Cookies
Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6
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