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.

6526–6550 of 21595

  • ModerateFDA (Food)·F-1447-2020·2020-09-09

    Sundial Herbal Products Recalls Ghanian Black Spice for Unapproved Drug Claims

    Sundial Herbal Products is recalling Ghanian Black Spice because the product is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1453-2020·2020-09-09

    Sundial Mango Bark Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mango Bark herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1504-2020·2020-09-09

    Sundial Jamaican Raw Honey Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Jamaican & Tropical Raw Honey because it is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***Jamaican & Tropical Raw Honey***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1461-2020·2020-09-09

    Sundial Herbal Products Recalls Dog Blood Herbal Product for Misbranding

    Sundial Herbal Products is recalling Dog Blood herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DOG BLOOD***1 oz.***USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE***"; packaged in clear plastic zip-top bag
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1560-2020·2020-09-09

    Bersih Hand Sanitizer Gel Recalled for cGMP Deviations

    Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel due to cGMP deviations. The product was distributed in the United States.

    Product
    Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1501-2020·2020-09-09

    Sundial Herbal Products Recalls Cocoa Balls for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Cocoa Balls because the product is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1555-2020·2020-09-09

    Jaloma Antiseptic Hand Sanitizer Recalled for cGMP Deviations

    Laboratorios Jaloma is recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2020·2020-09-09

    Randox Laboratories Recalls Amylase Reagents Due to Performance Failures

    Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.

    Product
    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1561-2020·2020-09-09

    Leiper's Fork Distillery Recalls Alcohol Antiseptic Topical Solution Due to Methanol Labeling

    Leiper's Fork Distillery is recalling 1,996 gallons of 70% Ethyl Alcohol Antiseptic Topical Solution because the product is labeled to contain methanol.

    Product
    Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2933-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1479-2020·2020-09-09

    Sundial White Jointa Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling White Jointa herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2928-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,444 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1259-2020·2020-09-02

    UNFI Recalls Temperature-Abused Eggs from Multiple Brands

    UNFI General Corporate is recalling 226 cases of eggs from multiple brands due to temperature abuse. The products were distributed in Illinois, Indiana, Missouri, and Wisconsin.

    Product
    The following products received from the UNFI Distribution Center Champaign, IL on 7/12/2020: Ditch Farms Eggs brand: Grade A Large (20/18ct; UPC 2009194510035) and (30/12ct; UPC 1004127044750) and (30/6ct; UPC 1009194510032) ; Grade A Large Brown (30/12ct; UPC 2009194510060)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2885-2020·2020-09-02

    Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors

    Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.

    Product
    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2875-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2902-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1540-2020·2020-09-02

    Rocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate

    Yusef Manufacturing is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm because the active ingredient Octisalate was found at 15% above the label claim.

    Product
    Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2901-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an ope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2020·2020-09-02

    RayCare Oncology Software Recalled for Offline Image Review Error

    RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

    Product
    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1258-2020·2020-09-02

    O Organics Tahini Recalled Due to Loose Metal Lids

    ACME Food Sales Inc. is recalling O Organics Tahini because some glass jars have loose-fitting metal lids that are not secured tightly.

    Product
    O Organics Tahini is 100% organic ground slightly roasted sesame seed paste, packaged in 16oz glass jar with metal screw on/off lid and has a paper anti tampering seal connecting the lid with the jar. UPC 0 79893 39024 6. The label is read in parts: "***O Organic TAHINI *** IN
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1548-2020·2020-09-02

    FDA Recalls Hand Sanitizer Gel Due to Manufacturing Deviations

    Resource Recovery & Trading LLC is voluntarily recalling 17,280 bottles of hand sanitizer gel due to cGMP deviations. The product was distributed in Alabama and Georgia.

    Product
    Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-1306-2020·2020-09-02

    Wegmans Recalls Soft Shell Crab Tempura Due to Listeria Risk

    Wegmans is recalling soft shell crab tempura products potentially contaminated with Listeria monocytogenes. Consumers should check their refrigerators and discard or return the product.

    Product
    Crab Soft Shell Tempura; Individual; Wegmans ready to cook prime soft-shell crab tempura; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2889-2020·2020-09-02

    BD SafetyGlide Syringes Recalled for Incorrectly Printed Scale Markings

    Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.

    Product
    BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2900-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2848-2020·2020-09-02

    Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction

    Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.

    Product
    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide