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.

676–700 of 2766

  • LowFDA (Drugs)·D-1839-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1840-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

    Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1841-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2291-2019·2019-08-28

    FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 2,079 MICRO-TEMP LT heat therapy systems because updated warnings indicate that exceeding 40°C for extended periods may cause tissue damage.

    Product
    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1743-2019·2019-08-21

    Glenmark Recalls Clotrimazole and Betamethasone Cream Due to Temperature Abuse

    Glenmark Pharmaceuticals is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream due to complaints of a liquidy texture caused by temperature abuse.

    Product
    CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2157-2019·2019-08-14

    PTS Lipid Panel Test Strips Recalled for MEMo Chip Labeling Error

    Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.

    Product
    PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioCh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1585-2019·2019-08-14

    Smart Sense Aspirin Recalled for Incorrect Expiration Date Labeling

    AAA Pharmaceutical is recalling Smart Sense Regular Strength Aspirin Tablets due to an incorrect expiration date on the label.

    Product
    Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2158-2019·2019-08-14

    Polymer Technology Systems Recalls Mislabeled Lipid Panel Test Strips

    Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.

    Product
    Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1980-2019·2019-08-14

    Sunchy Malta Beverage Recalled for Failing Taste Specifications

    Sunshine Bottling Co. is recalling specific lots of Sunchy Malta beverage because the product did not meet taste specifications.

    Product
    Sunchy Malta Pasteurized Non-Alcoholic Cereal Beverage in 7oz bottles 4 or 6/pack
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-2139-2019·2019-08-14

    Sage Products Recalls Independent Care System Due to Damaged Mouthpaste Tubes

    Sage Products Inc is voluntarily recalling a lot of Independent Care System kits because the included Sodium Bicarbonate Mouthpaste tubes may be cosmetically damaged.

    Product
    Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste a
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1558-2019·2019-08-07

    ICEE Cherry Scented Antibacterial Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling ICEE Cherry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1531-2019·2019-08-07

    Tootsie Roll Grape Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape Scented Antibacterial Hand Gel because stability testing was not conducted.

    Product
    Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1542-2019·2019-08-07

    NingBo Huize Recalls Cherry Scented Antibacterial Hand Gel for CGMP Deviations

    NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Cherry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1559-2019·2019-08-07

    NingBo Huize Recalls ICEE Blue Raspberry Hand Gel for Stability Testing Failures

    NingBo Huize Commodity Co., Ltd. is recalling ICEE Blue Raspberry Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1543-2019·2019-08-07

    NingBo Huize Recalls Watermelon Scented Antibacterial Hand Gel for CGMP Deviations

    NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Watermelon Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1538-2019·2019-08-07

    DOTS Scented Antibacterial Hand Gel Recalled for Stability Testing Deviations

    NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Orange because stability testing was not conducted on the product.

    Product
    DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1554-2019·2019-08-07

    NingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Air Heads Pink Lemonade Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1550-2019·2019-08-07

    Tootsie Roll Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Lime Scented Antibacterial Hand Gel because stability testing was not conducted.

    Product
    TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1530-2019·2019-08-07

    Good to Go Hand Sanitizer Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Good to Go Hand Sanitizer because stability testing was not conducted on the product.

    Product
    Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1545-2019·2019-08-07

    NingBo Huize Recalls CHARMS Antibacterial Hand Gel for CGMP Deviations

    NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Scented Antibacterial Hand Gel because stability testing was not conducted on the OTC products.

    Product
    CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1529-2019·2019-08-07

    NingBo Huize Recalls Hand Sanitizer for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling 35,500 units of Accent Care hand sanitizer because stability testing was not conducted.

    Product
    Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2133-2019·2019-08-07

    Xhale Assurance Nasal SpO2 Sensor Recall for Missing Instructions

    Xhale Assurance is recalling 701,272 Nasal Alar SpO2 Sensors because the Instructions for Use are missing steps for checking and changing the application site.

    Product
    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the n
    Category
    Medical Device
    Distribution
    Distributed nationwide