The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1626–1650 of 3531

  • ModerateFDA (Devices)·Z-1252-2023·2023-03-22

    BioFire Respiratory Panel 2.1 Recalled Due to Temperature Shipping Excursions

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0588-2023·2023-03-22

    Cannoli Cheesecake Recall: Undeclared Yellow 5 and Red 40 Color Additives

    Epic Baking is recalling Cafe' Intermezzo Cannoli Cheesecake tortes distributed in Georgia and Tennessee due to undeclared Yellow 5 and Red 40 color additives not listed on the label. No illnesses have been reported.

    Product
    Cafe' Intermezzo Cannoli Cheesecake 7 lbs Ingredients: Egg, Cream Cheese, Sugar, Ricotta Cheese, Whipped Cream, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), All-Purpose Flour, Chocolate Chips, Cannoli Cookies, Orange Syrup, Chocolate But
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0425-2023·2023-03-22

    Dietary Supplement Sub-Potency Recall: Healthy Sense Daily Multiple with Iron

    Mason Vitamins is recalling Healthy Sense Daily Multiple with Iron dietary supplements because the product contains insufficient levels of Vitamins A, B12, B5, C, and E compared to label claims.

    Product
    Healthy Sense Daily Multiple with Iron, Dietary Supplement, 20 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0594-2023·2023-03-22

    Epic Baking Cheesecake Recalled for Incomplete Sub-ingredient Disclosure

    Epic Baking is recalling 625 units of Cafe' Intermezzo Cookies and Cream Cheesecake sold in Georgia and Tennessee because the firm did not list all sub-ingredients. All major allergens were disclosed in the ingredient statement.

    Product
    Cafe' Intermezzo Cookies and Cream Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, Oreo Crust (Oreo Crust (Oreo Cookies, Butter), Oreo Cookies, Vanilla Extract, All-Purpose Flour, Hershey's Syrup, Corn Starch. Contains: Milk, eggs, wheat and soy. May contain tree nuts an
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0600-2023·2023-03-22

    Red Velvet Torte Recalled for Undeclared Food Coloring

    Epic Baking's Cafe' Intermezzo Red Velvet Torte is recalled due to undeclared Red 40 food coloring. The recall affects 279 tortes distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Red Velvet Torte 5.5 lbs Ingredients: Red Velvet Cake, Water, Vegetable Oil, Cream Cheese Frosting (Cream Cheese, Sugar, Butter, Shortening, Vanilla Extract), Chocolate Pudding Mix. Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0603-2023·2023-03-22

    Cafe' Intermezzo Traditional Cheesecake recalled for incomplete sub-ingredient disclosure

    Epic Baking recalled 323 units of Cafe' Intermezzo Traditional Cheesecake distributed in Georgia and Tennessee for failure to list sub-ingredients on the label. All major allergens are disclosed in the product's contains statement.

    Product
    Cafe' Intermezzo Traditional Cheesecake 5.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Vanilla Extract, Corn Starch Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0590-2023·2023-03-22

    Cheesecake Brownie Recalled for Undeclared Artificial Food Colorants

    Epic Baking's Cafe' Intermezzo Chocolate Candy Brownie Cheesecake was recalled for containing undeclared artificial food colorants. Approximately 98 units were distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Chocolate Candy Brownie Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Brownie Batter, Pretzel Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Pretzels, Cocoa Powder, Vanilla Extract), Chocolate Ganache (Chocolate Chips, Heavy Cream), M&M
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0464-2023·2023-03-22

    Evamist (Estradiol) Transdermal Spray Recalled for Failed Content Uniformity

    Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray nationwide because the spray content uniformity specification for standard deviation was not met at the 18-month stability time point.

    Product
    EVAMIST — EVAMIST (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0433-2023·2023-03-22

    DF 85% Cacao Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling DF 85% Cacao Bittersweet Chocolate Wafers (Item #54213, Lot #2347T540CL14) because the product may contain undeclared peanut residue, which poses a risk to consumers with peanut allergies.

    Product
    DF 85% Cacao Bittersweet Chocolate Wafer, Item # 54213. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate, Sugar, Sunflower Lecithin (an emulsifier), and Natural Vanilla Flavor. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0424-2023·2023-03-22

    Women's Daily Vitamins with Iron Recalled for Sub-Potent Formulation

    Mason Vitamins is recalling People's Choice Women's Daily Vitamins with Iron because the product contains less of five key vitamins than stated on the label. Approximately 224,279 bottles are affected.

    Product
    People's Choice Women's Daily Vitamins with Iron, 30 Tablets, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0601-2023·2023-03-22

    Café Intermezzo Strawberry Crème Torte Recalled for Undeclared Food Colorants

    Epic Baking is recalling 191 units of Café Intermezzo Strawberry Crème Torte due to undeclared synthetic food colorants in the buttercream. The product was distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Strawberry Cr¿me Torte 5.5 lbs Ingredients: White Cake, Water, Vegetable Oil, Strawberry Buttercream (Sugar, Shortening, Strawberry Jell-O, Vanilla Extract, Salt), Chocolate Pudding Mix, Strawberry Glaze, Red Chocolate Curls. Contains: Milk, eggs, wheat, and soy,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0414-2023·2023-03-15

    Organic Brussel Sprouts Recalled Due to Chlorpyrifos Pesticide Contamination

    4 Earth Farms is recalling organic brussel sprouts sold under multiple retail brands because the product tested positive for the pesticide Chlorpyrifos. The affected products were distributed to consumers across the United States and Canada.

    Product
    Brussel Sprouts 98.5% of product was packaged for retail and 110 cases were bulk Brands: 4 Earth Farms, Trader Joe s, Wegman s, O Organics, STO Kroger. Unit size: 2lbs (plastic bag), 1lbs (mesh bag and plastic bag), 14 oz (plastic bag), 12 oz (plastic bag), 10 oz (plastic bag),
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1227-2023·2023-03-15

    BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard

    The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.

    Product
    BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2023·2023-03-15

    Dental anaerobic glue recalled for incorrect expiration date labeling

    Preat Corp is recalling 652 units of PREAT NOBIL GRIP dental adhesive due to incorrect expiration dates on product labels. Consumers should verify lot numbers and contact the manufacturer.

    Product
    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2023·2023-03-15

    Phenylephrine HCl syringe recalled for manufacturing practice deviations

    Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.

    Product
    Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0448-2023·2023-03-15

    FDA Recalls Unguentine Original Ointment for Manufacturing Practice Deviations

    Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.

    Product
    Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0437-2023·2023-03-15

    FDA Recalls NaturalCare bioAllers Nasal Spray Due to Manufacturing Defects

    Nutraceutical Corporation recalls NaturalCare bioAllers Allergy Nasal Spray nationwide due to manufacturing quality deviations in raw materials. The recalled lots show discoloration and do not meet FDA Good Manufacturing Practice standards.

    Product
    NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0413-2023·2023-03-15

    Gem City Fine Foods Vegan Chocolate Cake Recalled for Incorrect Ingredient Labeling

    Gem City Fine Foods is recalling its GF Vegan Chocolate Cake (25 oz) due to an incorrect ingredients label that lists dairy, eggs, and soy as contents when the product does not contain them.

    Product
    Gem City Fine Foods GF Vegan Chocolate Cake, 25 oz, in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, LLC, 3403 S 1400 W, Ste C., West Valley City, UT 84119. UPC 855026-00142-1
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0440-2023·2023-03-15

    NaturalCare Children's Allergy Care Homeopathic Drops Recalled for CGMP Deviation

    Nutraceutical Corporation is recalling NaturalCare children's homeopathic allergy drops (Lot 222148) nationwide due to a manufacturing deviation in raw materials. No illnesses have been reported.

    Product
    NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2023·2023-03-15

    FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

    Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.

    Product
    Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0450-2023·2023-03-15

    FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations

    Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.

    Product
    Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0449-2023·2023-03-15

    Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations

    Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.

    Product
    Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2023·2023-03-15

    Unguentine Original Pain Relief Ointment Recalled for Manufacturing Process Deviations

    Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.

    Product
    Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2023·2023-03-15

    epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy

    Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.

    Product
    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2023·2023-03-15

    Medicated Balm Recalled for Manufacturing Process Deviations

    Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.

    Product
    Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
    Category
    Drug
    Distribution
    Distributed nationwide