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.

19351–19375 of 21751

  • ModerateFDA (Drugs)·D-724-2014·2014-01-22

    Aidapak Recalls Quinapril HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 20 mg Quinapril HCL tablets because they may be mislabeled as Multivitamin/Multimineral tablets.

    Product
    QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180055809
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-567-2014·2014-01-22

    Aidapak Recalls Isometheptene Mucate Capsules Due to Labeling Errors

    Aidapak Services, LLC is recalling Isometheptene Mucate capsules because they may be mislabeled as other medications. The error could lead to patients receiving the wrong drug.

    Product
    ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0750-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

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

    Product
    MCA5-05SD - 0.5 MM 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 (Drugs)·D-607-2014·2014-01-22

    Neomycin Sulfate Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Neomycin Sulfate tablets that may be mislabeled as Imipramine HCl. The error could lead to incorrect medication administration.

    Product
    NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51991073801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-712-2014·2014-01-22

    Aidapak Recalls Benazepril HCL Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Benazepril HCL 5 mg tablets because they may be mislabeled as Zinc Sulfate 220 mg capsules.

    Product
    BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-570-2014·2014-01-22

    Loratadine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Loratadine 10 mg tablets because they may be mislabeled as Glycopyrrolate or Omega-3 fatty acids.

    Product
    LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802065078
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-542-2014·2014-01-22

    Bisoprolol Fumarate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Bisoprolol Fumarate 5 mg tablets that may be mislabeled as Estropipate 0.75 mg.

    Product
    BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 29300012601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-728-2014·2014-01-22

    Fluconazole Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 50 mg fluconazole tablets that may be mislabeled as 200 mg tablets.

    Product
    FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-497-2014·2014-01-22

    FDA Recalls Melatonin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 3 mg melatonin tablets distributed in four western states because they may be mislabeled as other supplements.

    Product
    MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-470-2014·2014-01-22

    Aidapak Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Calcium Citrate tablets that may be mislabeled as Triamterene/HCTZ. The repacked drugs were distributed in four western states.

    Product
    CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-528-2014·2014-01-22

    Aidapak Recalls Metformin HCl Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling metFORMIN HCl 500 mg tablets because they may be mislabeled as Omega-3 Fatty Acid capsules.

    Product
    metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155010201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-481-2014·2014-01-22

    Aidapak Recalls Glucosamine/Chondroitin Capsules Due to Labeling Errors

    Aidapak Services, LLC is recalling Glucosamine/Chondroitin DS capsules because they may be mislabeled as other medications. The products were distributed in four western states.

    Product
    GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-502-2014·2014-01-22

    FDA Recalls Omeprazole Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as other medications.

    Product
    OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-562-2014·2014-01-22

    Lactobacillus Acidophilus Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lactobacillus Acidophilus capsules because they may be mislabeled as Docusate Sodium. Consumers should stop using the product.

    Product
    LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055746
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-576-2014·2014-01-22

    Aidapak Recalls Melatonin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1 mg Melatonin tablets because they may be mislabeled as other medications. The affected products were distributed in four western states.

    Product
    MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 47469000466
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-744-2014·2014-01-22

    Novartis Recalls Excedrin Sinus Headache Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling Excedrin Sinus Headache caplets because an unknown degradant was found during stability testing.

    Product
    Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0754-2014·2014-01-22

    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
    MCA5-15SB - 1.5MM 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-624-2014·2014-01-22

    FDA Recalls Cinacalcet HCL Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 30 mg Cinacalcet HCL tablets because they may be mislabeled as other medications like acetaminophen or ferrous sulfate.

    Product
    CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-636-2014·2014-01-22

    Sevelamer HCl Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Sevelamer HCl tablets that may be mislabeled as Ranolazine ER due to a labeling mixup.

    Product
    SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0755-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

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

    Product
    MCA5-15SD - 1.5MM 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 (Drugs)·D-726-2014·2014-01-22

    Aidapak Recalls Amlodipine Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 10 mg amlodipine besylate tablets that may be mislabeled as 5 mg finasteride tablets.

    Product
    amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-524-2014·2014-01-22

    Aidapak Recalls Simvastatin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 20 mg Simvastatin tablets because they may be mislabeled as Vitamin B Complex with C/Folic Acid.

    Product
    SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-617-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Capsules Due to Labeling Mixup

    Aidapak Services is recalling Vitamin B Complex capsules because they may be mislabeled as Sodium Chloride tablets. The recall covers 2,398 capsules distributed in four western states.

    Product
    VITAMIN B COMPLEX W/C Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629008001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0745-2014·2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odor Reports

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

    Product
    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2014·2014-01-22

    Anspach Micro Curved Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling Micro Curved Attachment Cutting Burrs because the indications for use were broader than validated and directions were unclear.

    Product
    Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide