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.

551–575 of 2738

  • LowFDA (Drugs)·D-1258-2020·2020-04-08

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1625-2020·2020-04-08

    Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1626-2020·2020-04-08

    Gentell Hydrogel Ag Wound Dressing Recalled for Registration Issues

    Gentell, Inc. is recalling Gentell Hydrogel Ag wound dressings because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0872-2020·2020-04-08

    Nature's Blend Folic Acid Recalled for Labeling Error

    National Vitamin Company is recalling Nature's Blend Folic Acid 1000 mcg bottles due to a front panel label error stating 1000 mg instead of 1000 mcg.

    Product
    Nature's Blend Folic Acid 1000 mcg Dietary Supplement, 1000-count bottle, Product Number: 1280, UPC 0-79854-51280-9
    Category
    Food
    Distribution
    18 states
  • LowFDA (Drugs)·D-1049-2020·2020-04-01

    FDA Recalls Colostat Homeopathic Remedy Due to Incorrect Labeling

    Grato Holdings, Inc. is recalling 659 bottles of Colostat homeopathic remedy because the indications on the product label are incorrect.

    Product
    COLOSTAT — COLOSTAT (RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1565-2020·2020-04-01

    Cook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Pericardiocentesis Sets because the printed expiration dates are incorrect. The products were distributed to seven US states and Canada.

    Product
    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-1029-2020·2020-03-25

    Strides Pharma Recalls Potassium Chloride Tablets Due to Oversized Size

    Strides Pharma Science Limited is recalling specific lots of Potassium Chloride Extended-Release Tablets because oversized tablets were found.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1470-2020·2020-03-18

    Integra NeuraGen Nerve Guide Recalled for Quality Control Error

    Integra LifeSciences is recalling 55 units of NeuraGen Nerve Guides because nonconforming product was mistakenly released for commercial use.

    Product
    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1055-2020·2020-03-18

    Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

    Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

    Product
    Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2020·2020-03-11

    Advanced Bionics Recalls SoundWave Professional Suite Software 3.2

    Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.

    Product
    SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0964-2020·2020-03-11

    Axia Pharmaceutical Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection because the company cannot assure the product's sterility.

    Product
    Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0868-2020·2020-03-11

    AAA Pharmaceutical Recalls Fexofenadine Tablets for Labeling Errors

    AAA Pharmaceutical, Inc. is recalling specific lots of Discount Drug Mart Fexofenadine Hydrochloride Tablets due to incorrect or missing lot and expiration dates.

    Product
    Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3…
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0859-2020·2020-03-04

    Akorn Recalls Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown particulate matter inside the tubes.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1353-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1389-2020·2020-03-04

    LivaNova SMART PERFUSION PACK INSPIRE 8S Recalled for Incorrect Cuvette Packaging

    LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.

    Product
    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1063-2020·2020-03-04

    Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

    Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

    Product
    Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0781-2020·2020-03-04

    Nature's Sunshine NutriSmart Soy Powder Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine NutriSmart soy protein powder because the flax seed ingredient contains an unapproved herbicide.

    Product
    Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con vitaminas y minerals; Vainilla Plastic HDPE jar Contenido Neto 510 g UPC: 0 80030910217 Product number: 6116-GE3091 Elaborado por: Nature's Sunshine Products Inc. 1655 North Main…
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1391-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1390-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical…
    Category
    Medical Device
    Distribution
    7 states