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.

11226–11250 of 21617

  • ModerateFDA (Devices)·Z-0661-2018·2018-02-28

    Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

    Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

    Product
    ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is in
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0477-2018·2018-02-28

    FDA Recalls Calcipotriene BP Due to Missing Stability Data

    American Pharmaceutical Ingredients is recalling Calcipotriene BP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2018·2018-02-28

    Amitriptyline HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data supporting the assigned expiration dates.

    Product
    Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2018·2018-02-28

    FDA Recalls Testosterone Cypionate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Testosterone Cypionate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0673-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size. The components are intended for use in total knee arthroplasty.

    Product
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2018·2018-02-28

    Cyclobenzaprine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2018·2018-02-28

    Flurbiprofen USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.

    Product
    Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2018·2018-02-28

    FDA Recalls Estrone USP for Prescription Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding because it lacks stability data and controls to support its expiration dates.

    Product
    Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0660-2018·2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0517-2018·2018-02-28

    Prilocaine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2018·2018-02-28

    FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.

    Product
    Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2018·2018-02-28

    FDA Recalls Ketamine HCl USP for Prescription Compounding Due to Stability Data Issues

    American Pharmaceutical Ingredients LLC is recalling Ketamine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2018·2018-02-28

    FDA Recalls Clindamycin Phosphate Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations

    American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.

    Product
    Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2018·2018-02-28

    Voluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues

    Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.

    Product
    Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0525-2018·2018-02-28

    FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.

    Product
    Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0496-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.

    Product
    Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0654-2018·2018-02-28

    Arrow Multi Lumen CVC Kit Recalled for Incorrect Springwire Guide

    Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.

    Product
    Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2018·2018-02-28

    FDA Recalls Levetiracetam USP for Prescription Compounding Due to Stability Issues

    American Pharmaceutical Ingredients LLC is recalling Levetiracetam USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2018·2018-02-28

    Hologic Recalls Rapid for TLiIQ System Kits Due to Unapproved Material

    Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.

    Product
    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0829-2018·2018-02-28

    Bob's Red Mill Organic Creamy Wheat Hot Cereal Recalled for Undeclared Wheat

    Bob's Red Mill is recalling Organic Creamy Wheat Hot Cereal because the back label incorrectly identifies the product as muffins, failing to declare wheat.

    Product
    Organic Creamy Wheat Hot Cereal, Item number 6097C244, Pack size: 24 oz bag, 4 bags in a case. UPC: 3997800992
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0679-2018·2018-02-28

    Vygon Recalls LifeGuard Huber Needles Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 396 units of LifeGuard Huber Needles because packaging adhesive gaps may compromise sterility.

    Product
    20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
    Category
    Medical Device
    Distribution
    0 states