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.

11251–11275 of 21617

  • 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-0506-2018·2018-02-28

    Lidocaine HCl USP Recalled for Missing Stability Data

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

    Product
    Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0494-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding

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

    Product
    Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0648-2018·2018-02-28

    Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

    Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Feedback and Injury Information

    Philips is recalling QCPR meters used with HeartStart defibrillators to inform users of correct pad placement and CPR-related injuries.

    Product
    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0531-2018·2018-02-28

    Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls

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

    Product
    Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2018·2018-02-28

    FDA Recalls Hydroxyprogesterone Caproate Due to Missing Stability Data

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

    Product
    Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0522-2018·2018-02-28

    Sumatriptan USP for Prescription Compounding Recalled Due to Stability Data Deficiencies

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

    Product
    Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2018·2018-02-28

    Naltrexone HCl USP Recalled Due to Missing Stability Data

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

    Product
    Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2018·2018-02-28

    FDA Recalls Leucovorin Calcium Due to Missing Stability Data

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

    Product
    Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0521-2018·2018-02-28

    Sumatriptan Succinate USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sumatriptan Succinate USP for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
    Category
    Drug
    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 (Drugs)·D-0487-2018·2018-02-28

    FDA Recalls Duloxetine HCl for Prescription Compounding Due to Stability Data Deficiencies

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

    Product
    Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0519-2018·2018-02-28

    Sildenafil Citrate USP Recalled Due to Missing Stability Data

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

    Product
    Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredien
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2018·2018-02-28

    Nandrolone Decanoate USP Recalled for Lack of Stability Data

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

    Product
    Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0534-2018·2018-02-28

    Verapamil HCl USP Recalled for Missing Stability Data and Controls

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

    Product
    Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    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-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 (Drugs)·D-0505-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.

    Product
    Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2018·2018-02-28

    FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

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

    Product
    Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0504-2018·2018-02-28

    Levofloxacin Hemihydrate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2018·2018-02-28

    FDA Recalls Doxycycline Hyclate Due to Missing Stability Data

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

    Product
    Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide