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.

151–175 of 261

  • LowCPSC·24072·2024-01-04

    H.H. Brown Redeemer Work Boots Recalled for Non-Puncture-Resistant Sole

    H.H. Brown Shoe Company is recalling about 2,360 Redeemer DH 5379 work boots sold from February 2023 through October 2023 because the sole is not puncture-resistant, posing an injury hazard. No injuries have been reported.

    Product
    Redeemer Men's Work Boot Model DH 5379
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0556-2024·2023-12-20

    Medical Device Instructions Update Recall for Navik 3D Mapping System

    APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.

    Product
    Navik 3D v2, REF NAVIK3D, 3D Mapping System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0072-2024·2023-11-01

    Vancomycin Hydrochloride IV Bags Recalled Nationwide for Labeling Issue

    Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.

    Product
    VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0066-2024·2023-11-01

    Methotrexate Sodium tablets recalled due to illegible markings and unsmooth surface

    West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because some tablets have unsmooth surfaces and illegible identification markings. The recall affects 2,673 cartons distributed to MS and OH.

    Product
    METHOTREXATE SODIUM — METHOTREXATE SODIUM (METHOTREXATE SODIUM)
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-2591-2023·2023-09-27

    Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling

    Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.

    Product
    Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1139-2023·2023-09-06

    Clindamycin Phosphate Topical Solution Recalled for Defective Container

    Contract Pharmaceuticals is recalling Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak under the cap. The recall affects 11,350 bottles distributed nationwide.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1696-2023·2023-06-14

    Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error

    Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.

    Product
    Alinity i Anti-TPO Reagent Kit, List Number 09P3521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0769-2023·2023-05-31

    Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.

    Product
    Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0770-2023·2023-05-31

    Fentanyl buccal tablets recalled due to incorrect or missing package insert

    Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.

    Product
    Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0756-2023·2023-05-31

    Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error

    Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.

    Product
    Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0766-2023·2023-05-31

    Fentanyl Buccal Tablets recalled due to missing or incorrect package insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.

    Product
    Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1587-2023·2023-05-24

    Diagnostic Imaging Systems Missing FDA Certification Label

    Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.

    Product
    ProxiDiagnost N90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0864-2023·2023-05-17

    Nitto Foods Immediately Pickled Dashi Recalled for Fish Labeling Issue

    Nitto Foods Immediately Pickled Dashi (5.5g x 2 bags, UPC 4902362032100) is being recalled due to labeling inconsistencies related to fish ingredients. The product was distributed across multiple US states and British Columbia.

    Product
    Nitto Foods Immediately Pickled Dashi 5.5g x 2 Bags UPC: 4902362032100
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0545-2023·2023-05-03

    FDA recalls Avicel PH-102 microcrystalline cellulose bulk ingredient for specification failure

    DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.

    Product
    Avicel PH-102 NF, Microcrystalline Cellulose NF, 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; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0710-2023·2023-04-19

    Perrona Hot Sauce Black Recalled Due to Mold Growth

    TIPPCON LLC is recalling Perrona Hot Sauce Black with Chiltepin Peppers due to mold growth detected on the outside of the bottle. No illnesses have been reported.

    Product
    Perrona Hot Sauce Black with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 75 03016 55511 1 packaged in a PET bottle, 12 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0535-2023·2023-04-19

    Prescription Epinephrine Kits Recalled for Incorrect NDC Number on Carton

    Focus Health Group is recalling 246 kits of Epinephrine Professional nationwide due to an incorrect NDC number printed on the outer carton. The labeling error does not affect the drug's safety or effectiveness.

    Product
    EPINEPHRINE PROFESSIONAL — EPINEPHRINE PROFESSIONAL (EPINEPHRINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0711-2023·2023-04-19

    Perrona Hot Sauce Green Recalled Due to Mold Growth on Bottle Exterior

    TIPPCON LLC is recalling Perrona Hot Sauce Green with Chiltepin Peppers due to mold growth on the outside of the bottle. Approximately 8,230 cases were distributed nationwide.

    Product
    Perrona Hot Sauce Green with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 7 503016 555098 packaged in a PET bottle, 12 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0696-2023·2023-04-12

    Shirakiku Furikake Seaweed Flakes Recalled for Incorrect Crustacean Labeling

    Wismettac Asian Foods is recalling Shirakiku Furikake Seasoned Roasted Seaweed Flakes Spicy due to incorrect crustacean labeling. The company distributed 17,517 packages across 22 states.

    Product
    FURIKAKE SEASONED ROASTED SEAWEED FLAKES SPICY Product #38246 Brand name: Shirakiku Distributed by: Wismettac Asian Foods, Inc. 13409 Orden Drive Santa Fe Springs, CA 90670
    Category
    Food
    Distribution
    22 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 (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-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-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-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 (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