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.

5951–5975 of 21595

  • ModerateFDA (Drugs)·D-0360-2021·2021-04-21

    Spartan Chemical Recalls foamyiQ Hand Sanitizer Due to Manufacturing Deviations

    Spartan Chemical Company is voluntarily recalling 26,328 cartridges of foamyiQ Lemon Blossom Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2021·2021-04-21

    Vectornate Recalls MedSchenker Smart Transport Medium Due to Discoloration

    Vectornate USA Inc is recalling 130,000 MedSchenker Smart Transport Medium systems due to discoloration and turbidity caused by a longer monsoon season at the manufacturing facility.

    Product
    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laborator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2021·2021-04-21

    Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

    Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

    Product
    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2021·2021-04-21

    Novo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse

    Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    SAXENDA — SAXENDA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 960 containers of Lite'n Foamy Healthcare Personnel Handwash due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH — LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2021·2021-04-21

    EOS Imaging Recalls EOSedge Systems Due to Measurement Errors

    EOS Imaging is recalling 11 EOSedge systems because they may produce inaccurate 2D measurements and image resizing errors when patients are not positioned antero-posteriorly.

    Product
    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisitio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0323-2021·2021-04-14

    Washington Homeopathic Products Recalls LCL-2-0191 Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling LCL-2-0191 because it was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0431-2021·2021-04-14

    Toasted Oat Macadamia Chunk Granola Recalled for Mold-Containing Ingredient

    The Toasted Oat is recalling Macadamia Chunk Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Macadamia Chunk Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Macadamia Chunk ( 5 - 28.3g bars per pack/6 packs per case).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1340-2021·2021-04-14

    Medtronic HVAD Battery Recall for Potential Controller Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1352-2021·2021-04-14

    Clerio Vision Recalls Extreme H2O 59% Contact Lenses for Mislabeled Power

    Clerio Vision is recalling 153 Extreme H2O 59% contact lenses because they may be mislabeled with the incorrect lens power.

    Product
    EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2021·2021-04-14

    Cosette Recalls Mometasone Furoate Topical Solution Due to CGMP Deviations

    Cosette Pharmaceuticals is recalling specific lots of Mometasone Furoate Topical Solution due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0385-2021·2021-04-14

    New Generation Wellness Recalls Vegan Vitamin D3 Tablets for Stability Issues

    New Generation Wellness Inc. is recalling 2,330 bottles of Vegan Vitamin D3 tablets because stability samples showed potency below the label claim.

    Product
    VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100cc amber glass bottles. UPC 7 19985 61831 4; UPC 6 10265 58337 0; UPC 4 01008 61831 8; UPC 4 02008 61831 5. Store in a cool, dry place. Product is sold under 72 private labels: A Moveable Feast; Akin's Natural Foods;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1362-2021·2021-04-14

    Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1338-2021·2021-04-14

    Medtronic HVAD Alarm Adapter Recalled for Potential Port Damage

    Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.

    Product
    Medtronic HVAD Alarm Adapter, Product Number: 1450
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1355-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits

    Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1358-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Pro Series Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1353-2021·2021-04-14

    Gf Health Products Recalls Drop Arm Versamode Due to Incorrect Casters

    Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.

    Product
    Drop Arm Versamode"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2021·2021-04-14

    Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization

    Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.

    Product
    Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0430-2021·2021-04-14

    Toasted Oat Blueberry Cobbler Granola Recalled for Mold Contamination

    The Toasted Oat is recalling Blueberry Cobbler Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Blueberry Cobbler Soft Granola (6 -10 oz pouches per case); and Soft Granola Crumble Bars Blueberry Cobbler (5 - 28.3g bars per pack/6 packs per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1356-2021·2021-04-14

    Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.

    Product
    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0328-2021·2021-04-14

    X-Gen Recalls Neomycin Sulfate Tablets Due to Microbiological Failure

    X-Gen Pharmaceuticals is recalling Neomycin Sulfate Tablets 500mg because a microbiological assay failed to meet stability specifications.

    Product
    Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
    Category
    Drug
    Distribution
    Distributed nationwide