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.

19376–19400 of 21751

  • ModerateFDA (Drugs)·D-501-2014·2014-01-22

    Aidapak Recalls Omeprazole Capsules Due to Potential Labeling Mixup

    Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Cyanocobalamin or Omega-3 fatty acid products.

    Product
    OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-472-2014·2014-01-22

    FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Tizanidine HCl. The error could lead to patients taking the wrong medication.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-716-2014·2014-01-22

    Aidapak Recalls Quetiapine Fumarate Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Quetiapine Fumarate 25 mg tablets because they may be mislabeled as Chlordiazepoxide HCl capsules.

    Product
    QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862048901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-499-2014·2014-01-22

    Aidapak Recalls Itraconazole Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Itraconazole capsules because they may be mislabeled as Famciclovir tablets. The error could lead to patients receiving the wrong medication.

    Product
    ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-628-2014·2014-01-22

    Aidapak Recalls Metoprolol Tartrate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 402 Metoprolol Tartrate tablets because they may be mislabeled as Docusate Sodium capsules.

    Product
    METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-583-2014·2014-01-22

    Aidapak Recalls D-Alpha Tocopheryl Acetate Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling D-Alpha Tocopheryl Acetate capsules because they may be mislabeled as Cyanocobalamin tablets.

    Product
    D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348041010
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-668-2014·2014-01-22

    Metoprolol Succinate ER Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Metoprolol Succinate ER 200 mg tablets due to a potential labeling mixup. The affected repacked drugs were distributed in four western states.

    Product
    METOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62037083301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-503-2014·2014-01-22

    FDA Recalls Omeprazole Capsules Due to Potential Labeling Mixup

    Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Benzocaine/Menthol lozenges. The FDA classifies this as a Class II recall.

    Product
    OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-590-2014·2014-01-22

    Aidapak Recalls Hydralazine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets because they may be mislabeled as Docusate Calcium 240 mg capsules.

    Product
    HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-715-2014·2014-01-22

    Rifaximin Tablets Recalled for Potential Mislabeling as Toprol

    Aidapak Services is recalling Rifaximin 200 mg tablets that may be mislabeled as Toprol 25 mg. The repacked drugs were distributed in four western states.

    Product
    rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-664-2014·2014-01-22

    Quetiapine Fumarate Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Quetiapine Fumarate 25 mg tablets because they may be mislabeled as multivitamin or aspirin products.

    Product
    QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-598-2014·2014-01-22

    Solifenacin Succinate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Solifenacin Succinate 5 mg tablets because they may be mislabeled as Bromocriptine Mesylate 2.5 mg.

    Product
    SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51248015001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-686-2014·2014-01-22

    Aidapak Recalls Benzoicaine/Menthol Lozenges Due to Labeling Error

    Aidapak Services, LLC is recalling Benzoicaine/Menthol lozenges because they may be mislabeled as Cholecalciferol/Calcium/Phosphorus tablets.

    Product
    BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-696-2014·2014-01-22

    Aidapak Recalls Colchicine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific lots of Colchicine 0.6 mg tablets because they may be mislabeled as other medications.

    Product
    COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-498-2014·2014-01-22

    FDA Recalls Galantamine Capsules Due to Potential Labeling Error

    Aidapak Services is recalling Galantamine HBr ER capsules because they may be mislabeled as Famotidine tablets.

    Product
    GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0752-2014·2014-01-22

    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
    MCA5-07SD - 0.7MM 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-475-2014·2014-01-22

    FDA Recalls Pseudoephedrine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Pseudoephedrine HCL 60 mg tablets because they may be mislabeled as Repaglinide 1 mg tablets.

    Product
    PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-515-2014·2014-01-22

    Aidapak Recalls Allopurinol Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Allopurinol 300 mg tablets because they may be mislabeled as Cholecalciferol 400 units.

    Product
    ALLOPURINOL Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714004204
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-667-2014·2014-01-22

    Aidapak Recalls Ranolazine ER Tablets Due to Labeling Mixup

    Aidapak Services is recalling RANOLAZINE ER 500 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0760-2014·2014-01-22

    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
    MCA7-05SD - 0.5MM 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-483-2014·2014-01-22

    Aidapak Recalls Diphenhydramine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling diphenhydramine HCl tablets because they may be mislabeled as atorvastatin, prenatal vitamins, or venlafaxine.

    Product
    diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-663-2014·2014-01-22

    Olanzapine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Olanzapine 7.5 mg tablets due to a potential labeling mixup with Nortriptyline HCL capsules.

    Product
    OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-734-2014·2014-01-22

    Aidapak Recalls Melatonin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1 mg Melatonin tablets that may be mislabeled as Omega-3 fatty acid capsules. The error involves a potential mix-up between two different products.

    Product
    MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 74312002832
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-719-2014·2014-01-22

    Aidapak Recalls Mislabeled Carbamazepine ER Capsules

    Aidapak Services, LLC is recalling 229 capsules of carbamazepine ER 200 mg due to a labeling mixup where the product may be mislabeled as acamprosate calcium.

    Product
    carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
    Category
    Drug
    Distribution
    4 states