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.

19226–19250 of 21751

  • ModerateFDA (Drugs)·D-610-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 50,000-unit Cholecalciferol capsules because they may be mislabeled as Fenofibrate tablets. The repacked drugs were distributed in four western states.

    Product
    CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 53191036201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0778-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-677-2014·2014-01-22

    Aidapak Recalls Hydroxychloroquine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydroxychloroquine Sulfate 200 mg tablets because they may be mislabeled as Guanfacine HCl 1 mg.

    Product
    HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-471-2014·2014-01-22

    FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Valsartan, Lactobacillus, or Pyridoxine.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0725-2014·2014-01-22

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

    GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

    Product
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-467-2014·2014-01-22

    Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-520-2014·2014-01-22

    Aidapak Recalls Losartan Potassium Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Losartan Potassium 25 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058102
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-586-2014·2014-01-22

    Glycopyrrolate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Glycopyrrolate 2 mg tablets because they may be mislabeled as Lactobacillus tablets.

    Product
    GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0756-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-537-2014·2014-01-22

    Aidapak Recalls Lactase Enzyme Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lactase Enzyme Tablets because they may be mislabeled as other medications. The recall covers 2,872 tablets distributed in four western states.

    Product
    LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385014976
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0753-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1393-2014·2014-01-22

    Jensen's Recalls Low Salt Vacuum Packaged Smoked Salmon Products

    Jensen's Old Fashioned Smokehouse is recalling low salt, vacuum packaged smoked salmon products not labeled 'KEEP FROZEN'.

    Product
    Low salt, vacuum packaged, Hot Smoked King Nova Salmon. The following is information on the individual products for Alaska King Seafoods brand: All AKS stands for Alaska King Seafoods product labels contain the following statement above or below the product name and/or…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-588-2014·2014-01-22

    Aidapak Recalls Doxycycline Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Doxycycline Monohydrate capsules because they may be mislabeled as Diphenhydramine or Dutasteride.

    Product
    DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0758-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.

    Product
    MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-541-2014·2014-01-22

    Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0777-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.

    Product
    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-698-2014·2014-01-22

    FDA Recalls Mislabeled Febuxostat Tablets Due to Label Mixup

    Aidapak Services is recalling Febuxostat 40 mg tablets that may be mislabeled as other medications due to a labeling error.

    Product
    FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-703-2014·2014-01-22

    Aidapak Recalls Disulfiram Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Disulfiram 250 mg tablets because they may be mislabeled as Pyridoxine HCl 50 mg.

    Product
    DISULFIRAM Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980017101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-538-2014·2014-01-22

    Nicotine Polacrilex Gum Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Nicotine Polacrilex Gum, 2 mg, due to a potential labeling mixup with Saccharomyces boulardii capsules.

    Product
    NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24385059471
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-640-2014·2014-01-22

    Aripiprazole Tablets Recalled Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Aripiprazole 15 mg tablets because they may be mislabeled as Atomoxetine or Pramipexole.

    Product
    ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-730-2014·2014-01-22

    Verapamil HCL ER Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Verapamil HCL ER 240 mg tablets because they may be mislabeled as Trifluoperazine HCL 1 mg.

    Product
    VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-678-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Metoprolol Tartrate tablets because they may be mislabeled as Pioglitazone or Levothyroxine Sodium.

    Product
    METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304057901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-669-2014·2014-01-22

    FDA Recalls Isosorbide Mononitrate Tablets Due to Labeling Error

    Aidapak Services is recalling Isosorbide Mononitrate 10 mg tablets that may be mislabeled as Ascorbic Acid 250 mg. The error affects specific lots distributed in four western states.

    Product
    ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-495-2014·2014-01-22

    Aidapak Recalls Naproxen Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Naproxen 500 mg tablets because they may be mislabeled as Thiothixene or Hydrochlorothiazide.

    Product
    NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901
    Category
    Drug
    Distribution
    4 states