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.

19326–19350 of 21751

  • ModerateFDA (Drugs)·D-655-2014·2014-01-22

    Aidapak Recalls Cyproheptadine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Cyproheptadine HCL 4 mg tablets because they may be mislabeled as other medications.

    Product
    CYPROHEPTADINE HCL Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60258085001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-565-2014·2014-01-22

    Nifedipine Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Nifedipine 10 mg capsules due to a potential label mixup with multivitamin products.

    Product
    NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-479-2014·2014-01-22

    FDA Recalls Zinc Sulfate Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Zinc Sulfate capsules that may be mislabeled as Phosphorus tablets. The error involves a label mixup on repacked products.

    Product
    ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-580-2014·2014-01-22

    FDA Recalls Lactobacillus GG Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lactobacillus GG capsules because they may be mislabeled as guaiFENesin ER tablets. The repacked drugs were distributed in four western states.

    Product
    LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-627-2014·2014-01-22

    Aidapak Recalls Tizanidine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Tizanidine HCL tablets because they may be mislabeled as Nicotine Polacrilex or Nifedipine ER.

    Product
    tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-666-2014·2014-01-22

    FDA Recalls Esterified Estrogens Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Esterified Estrogens tablets because they may be mislabeled as Etodolac. The repacked drugs were distributed in four western states.

    Product
    ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61570007301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-496-2014·2014-01-22

    Omega-3 Fatty Acid Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling 1000 mg Omega-3 Fatty Acid capsules because they may be mislabeled as Nortriptyline HCL 50 mg.

    Product
    OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 05445800022
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0775-2014·2014-01-22

    Lab Vision Estrogen Receptor Antibody Recalled for Performance Issues

    Lab Vision Corporation is recalling Estrogen Receptor AB-11 antibody because in-house testing showed no staining on breast cancer tissues.

    Product
    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-561-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Vitamin B Complex tablets because they may be mislabeled as Omeprazole or Prednisone.

    Product
    VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055540
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-536-2014·2014-01-22

    Erythromycin Tablets Recalled for Potential Mislabeled as Methylprednisolone

    Aidapak Services is recalling Erythromycin DR EC tablets that may be mislabeled as methylprednisolone. The error could lead to patients receiving the wrong medication.

    Product
    ERYTHROMYCIN DR EC Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24338012213
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-487-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 5,000-unit Cholecalciferol capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-509-2014·2014-01-22

    Aidapak Recalls Pramipexole Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets because they may be mislabeled as Multivitamin/Multimineral or Perphenazine.

    Product
    PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009190
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-604-2014·2014-01-22

    Carbamazepine ER Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as acarbose due to a label mixup.

    Product
    carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672412401
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-564-2014·2014-01-22

    Misoprostol Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Misoprostol tablets that may be mislabeled as Quinapril HCl. The error could lead to patients receiving the wrong medication.

    Product
    MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-727-2014·2014-01-22

    Ribavirin Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Ribavirin capsules that may be mislabeled as Modafinil or Desipramine. The error involves incorrect product identification on the packaging.

    Product
    RIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382026007
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-658-2014·2014-01-22

    Fosinopril Sodium Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 20 mg Fosinopril Sodium tablets that may be mislabeled as Tolterodine Tartrate ER capsules.

    Product
    FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251102
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-595-2014·2014-01-22

    Aidapak Recalls Torsemide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 10 mg Torsemide tablets because they may be mislabeled as 50 mg Pyridoxine HCl tablets.

    Product
    TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111091601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-683-2014·2014-01-22

    Aidapak Recalls GuaiFENesin ER Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling guaiFENesin ER tablets because they may be mislabeled as prenatal multivitamin or other medications.

    Product
    guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-643-2014·2014-01-22

    Aidapak Recalls Colestipol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Colestipol HCL Micronized Tablets because they may be mislabeled as rifAXIMin.

    Product
    COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762045001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-593-2014·2014-01-22

    Trazodone HCl Tablets Recalled Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Amantadine HCl 100 mg.

    Product
    traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0773-2014·2014-01-22

    GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors

    GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.

    Product
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-486-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2,399 tablets of Cholecalciferol 1000 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-680-2014·2014-01-22

    FDA Recalls Mislabelled Eszopiclone Tablets Distributed by Aidapak Services

    Aidapak Services is recalling Eszopiclone 3 mg tablets that may be mislabeled as Cholecalciferol 1000 units. The error involves specific pedigree and expiration codes.

    Product
    ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0759-2014·2014-01-22

    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
    MCA5-2SD - 2MM 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 (Devices)·Z-0746-2014·2014-01-22

    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 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide