The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

251–275 of 2766

  • LowFDA (Food)·F-0586-2023·2023-03-22

    Cafe' Intermezzo B-52 Cheesecake Recalled for Missing Sub-Ingredient Disclosure

    Epic Baking recalls Cafe' Intermezzo B-52 Cheesecake due to incomplete ingredient labeling. All major allergens are properly listed, but the product failed to disclose sub-ingredients of compound ingredients.

    Product
    Cafe' Intermezzo B-52 Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, White Chocolate, Chocolate Ganache (Chocolate Chips, Heavy Cream), Oreo Crust (Oreo Cookies, Butter), Chocolate Buttercream Frosting (Sugar, Shortening, Milk, Cocoa Powder, Vanilla Extract, Salt), Iris
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0606-2023·2023-03-22

    Epic Baking Cheesecake Recalled for Incomplete Sub-Ingredient Labeling

    Epic Baking is recalling Cafe' Intermezzo White Chocolate Raspberry Cheesecake because sub-ingredients were not listed on the product label, though major allergens were properly disclosed.

    Product
    Cafe' Intermezzo White Chocolate Raspberry Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, White Chocolate Ganache (White Chocolate, Heavy Cream), Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Raspberries, Raspberry Syrup, Vanill
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0593-2023·2023-03-22

    Cafe' Intermezzo Cookie Dough Cheesecake Recalled for Incomplete Sub-Ingredient Labeling

    Epic Baking recalls 102 units of Cafe' Intermezzo Cookie Dough Cheesecake distributed to Georgia and Tennessee due to incomplete sub-ingredient labeling. All major allergens are properly disclosed.

    Product
    Cafe' Intermezzo Cookie Dough Cheesecake 7.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Whipped Cream, Chocolate Ganache (Chocolate Chips, Heavy Cream), Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Chocolate-Dipped Cookies (Chocolate Chips, Butter
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0591-2023·2023-03-22

    Cafe' Intermezzo Chocolate Peanut Butter Cheesecake Recalled for Missing Sub-Ingredient Information

    Epic Baking is recalling 134 units of Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake distributed to Georgia and Tennessee because the firm failed to list sub-ingredients on the label.

    Product
    Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Chocolate Ganache (Chocolate Chips, Heavy Cream), Peanut Butter, Graham Cracker Crust (Graham Cracker Crumbs, Butter Sugar, Vanilla Extract, Cinnamon), Reese's Cups, Vanilla Ex
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0602-2023·2023-03-22

    Epic Baking Recalls Tiramisu Cheesecake Due to Incomplete Ingredient Labeling

    Epic Baking recalls Cafe' Intermezzo Tiramisu Cheesecake (6.5 lbs) shipped to GA and TN because sub-ingredients were not fully listed on the label, though all major allergens were disclosed.

    Product
    Cafe' Intermezzo Tiramisu Cheesecake 6.5 lbs Ingredients: Eggs, Cream Cheese, Sugar, Coffee, Whipped Cream, Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Cocoa Powder, Corn Starch, Lady Fingers Mixture (Coffee, Lady Fingers, Kapali Coffee Liqueur, E
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0351-2023·2023-03-08

    Avicel PH-200 pharmaceutical excipient recalled for failed conductivity specification

    DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.

    Product
    Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copen
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1059-2023·2023-02-15

    Face Masks Packaged in Incorrect Dispenser Boxes with Mismatched Labeling

    73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.

    Product
    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0402-2023·2022-12-14

    Medical Device Recall: Missing Instructions for Bipolar Surgical Forceps

    CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0070-2023·2022-11-30

    Phenytoin Sodium Injection Recalled for Missing Vial Barcode

    Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.

    Product
    PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0069-2023·2022-11-30

    Phenytoin Sodium Injection Recalled for Missing Barcode on Vial Label

    Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.

    Product
    PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0202-2023·2022-11-23

    Urological Irrigation Kit Recalled for Illegible Barcode Labels

    Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.

    Product
    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0132-2023·2022-11-02

    Vortex MP Port Titanium Recalled for Missing Printed Instructions

    Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.

    Product
    Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1551-2022·2022-10-12

    Tranexamic Acid Injection Recalled for Metal Particulate Matter

    AuroMedics Pharma LLC is recalling one lot of Tranexamic Acid Injection due to the presence of metal particles found in a vial. The affected product was distributed nationwide.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0004-2023·2022-10-12

    Fila Manila Coconut Jam recalled for undeclared gluten

    Fila Manila Coconut Jam (12 oz, UPC 860003619353) is being recalled because it contains undeclared gluten. Consumers with gluten sensitivity should not consume the product.

    Product
    Fila Manila Coconut Jam NET WT. 12 OZ (340g) UPC:860003619353
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0006-2023·2022-10-12

    Antibacterial Hand Wash Recalled for Incorrect Scent Label

    Woodbine Products is recalling FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH due to incorrect scent information on the label. The affected lots VDAF017 and VDAF018 were distributed in North Carolina, and no illnesses have been reported.

    Product
    FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH — FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1798-2022·2022-10-05

    AquaGuard Wound Dressing Recall Due to Facility Temperature Excursions

    TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.

    Product
    a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1796-2022·2022-10-05

    Mckesson DermaCol Collagen Dressings Recalled for Storage Temperature Excursion

    Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.

    Product
    a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dress
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2022·2022-09-21

    Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution

    Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.

    Product
    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1304-2022·2022-08-10

    Tacrolimus Ointment Recalled for Defective Containers That Split

    Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.

    Product
    TACROLIMUS — TACROLIMUS (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1299-2022·2022-08-03

    Juice Beauty lip moisturizer recalled for failed dissolution specifications

    Juice Beauty The Organic Solution SPF 8 lip moisturizer is being recalled due to failed dissolution specifications. The recall affects 35,313 tubes distributed in California.

    Product
    Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1465-2022·2022-08-03

    ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label

    Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.

    Product
    ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2022·2022-07-27

    Erythropoietin Control Product Instructions Contain Incorrect CE Marking

    R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.

    Product
    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1393-2022·2022-07-27

    NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity

    Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.

    Product
    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing S
    Category
    Medical Device
    Distribution
    19 states
  • LowFDA (Drugs)·D-1173-2022·2022-07-13

    Mometasone Furoate Topical Solution Recalled Due to Defective Containers

    Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.

    Product
    MOMETASONE FUROATE — MOMETASONE FUROATE (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide