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.

19301–19325 of 21751

  • ModerateFDA (Devices)·Z-0744-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-546-2014·2014-01-22

    Magnesium Gluconate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Magnesium Gluconate tablets that may be mislabeled as Fluvastatin capsules due to a label mixup.

    Product
    MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000322
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-707-2014·2014-01-22

    Promethazine HCL Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Promethazine HCL tablets that may be mislabeled as Cholecalciferol due to a labeling mixup.

    Product
    PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-708-2014·2014-01-22

    Aidapak Recalls Flecaïnide Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Flecaïnide Acetate tablets that may be mislabeled as Vitamin B Complex with C due to a labeling error.

    Product
    FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-547-2014·2014-01-22

    FDA Recalls Mislabeled Melatonin Tablets Distributed by Aidapak Services

    Aidapak Services is recalling 1 mg melatonin tablets that may be mislabeled as cranberry extract or glycopyrrolate. The FDA classifies this as a Class II recall.

    Product
    MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-517-2014·2014-01-22

    Fluoxetine Capsules Recalled Due to Potential Labeling Error

    Aidapak Services is recalling Fluoxetine HCl capsules because they may be mislabeled as Pancrelipase DR.

    Product
    FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0763-2014·2014-01-22

    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 were unclear.

    Product
    MCA7-08SD - 0.8MM 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-713-2014·2014-01-22

    Aidapak Recalls Benazepril HCL Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 799 Benazepril HCL tablets because they may be mislabeled as other medications.

    Product
    BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075410
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-662-2014·2014-01-22

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atorvastatin Calcium 80 mg tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505267109
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-652-2014·2014-01-22

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 500 mg Ascorbic Acid tablets that may be mislabeled as Febuxostat 40 mg. The error could lead to incorrect medication administration.

    Product
    ASCORBIC ACID Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258014101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-665-2014·2014-01-22

    Quetiapine Fumarate Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 1,300 Quetiapine Fumarate 100 mg tablets because they may be mislabeled as other medications.

    Product
    QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-625-2014·2014-01-22

    Cinacalcet HCL Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Cinacalcet HCL 60 mg tablets because they may be mislabeled as Ranolazine ER 500 mg.

    Product
    CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-492-2014·2014-01-22

    Magnesium Chloride Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Magnesium Chloride tablets that may be mislabeled as Selegiline HCL or Phosphorus due to a label mixup.

    Product
    MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904791152
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-589-2014·2014-01-22

    Aidapak Recalls Diltiazem HCL ER Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Diltiazem HCL ER Capsules, 240 mg, because they may be mislabeled as Nicotine Polacrilex or Paroxetine HCl.

    Product
    DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0761-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

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

    Product
    MCA7-06SD - 0.6MM 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 (Devices)·Z-0713-2014·2014-01-22

    Radiometer pO2 Membrane Units Recalled Due to Incorrect Inner Solution

    Radiometer America is recalling pO2 D999 membrane units because they were produced with the wrong inner solution, causing calibration failures.

    Product
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-490-2014·2014-01-22

    FDA Recalls Ferrous Sulfate Tablets Due to Potential Label Mixup

    Aidapak Services is recalling ferrous sulfate tablets that may be mislabeled as ramipril capsules. The error involves a label mixup on repacked drugs.

    Product
    FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-706-2014·2014-01-22

    Aidapak Recalls Folic Acid Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 1 mg Folic Acid tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-616-2014·2014-01-22

    Aidapak Recalls Glucosamine/Chondroitin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Glucosamine/Chondroitin capsules because they may be mislabeled as Fexofenadine HCL tablets.

    Product
    GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54458010022
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-638-2014·2014-01-22

    Multivitamin Chew Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Multivitamin/Multimineral Chew Tablets because they may be mislabeled as Levothyroxine Sodium or Lactobacillus Acidophilus.

    Product
    MULTIVITAMIN/MULTIMINERAL Chew Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 58914001460
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-674-2014·2014-01-22

    Aidapak Recalls OXcarbazepine Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling OXcarbazepine 600 mg tablets that may be mislabeled as Lactase Enzyme 3000 units. The error could lead to patients receiving the wrong medication.

    Product
    OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-480-2014·2014-01-22

    Zinc Sulfate Capsules Recalled for Potential Mislabeling as Sertraline

    Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Sertraline HCL tablets. The error could lead to patients taking the wrong medication.

    Product
    ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-659-2014·2014-01-22

    Cilostazol Tablets Recalled for Potential Labeling Mixup with Dutasteride

    Aidapak Services is recalling Cilostazol 100 mg tablets due to a labeling mixup where they may be mislabeled as Dutasteride 0.5 mg capsules.

    Product
    CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-717-2014·2014-01-22

    Aidapak Recalls Irbesartan Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 150 mg Irbesartan tablets because they may be mislabeled as Atropine Sulfate/Diphenoxylate HCl or Cholecalciferol.

    Product
    IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-654-2014·2014-01-22

    Magnesium Gluconate Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Magnesium Gluconate Dihydrate tablets because they may be mislabeled as hydrALAZINE HCl.

    Product
    MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258017201
    Category
    Drug
    Distribution
    4 states