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.

19101–19125 of 21751

  • ModerateFDA (Drugs)·D-1013-2014·2014-01-29

    Aidapak Recalls Amantadine HCL Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Amantadine HCL 100 mg tablets because they may have been mislabeled as other medications.

    Product
    AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-931-2014·2014-01-29

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 100 mcg cyanocobalamin tablets because they may have been mislabeled as guaiFENesin ER 600 mg tablets.

    Product
    CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536354201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-916-2014·2014-01-29

    Potassium Acid Phosphate Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Potassium Acid Phosphate tablets due to a potential label mixup with prednisone. The repacked drugs were distributed in four western states.

    Product
    POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00486111101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-943-2014·2014-01-29

    FDA Recalls Vitamin B Complex Capsules Due to Labeling Error

    Aidapak Services is recalling Vitamin B Complex capsules that may have been mislabeled as Acarbose tablets. The error involves a label mixup.

    Product
    VITAMIN B COMPLEX, Capsule, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536478701.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-780-2014·2014-01-29

    Aidapak Recalls Tolterodine Tartrate ER Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Tolterodine Tartrate ER capsules because they may be mislabeled as Ranolazine ER or Ferrous Sulfate.

    Product
    TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-833-2014·2014-01-29

    Aidapak Recalls Sotalol HCL Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Sotalol HCL 80 mg tablets because they may have been mislabeled as Diltiazem HCL or Propranolol HCL ER.

    Product
    SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-778-2014·2014-01-29

    Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets

    Aidapak Services is recalling 20 mg Pantoprazole Sodium DR tablets because they may be mislabeled as Hyoscyamine Sulfate or Multivitamin/Multimineral.

    Product
    PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0814-2014·2014-01-29

    Bard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters

    Bard Access Systems is recalling MRI Low Profile Single Lumen ports because some silicone catheters may be undersized to 5.3 Fr instead of the labeled 6.6 Fr.

    Product
    MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-769-2014·2014-01-29

    Raloxifene HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Raloxifene HCL tablets due to a potential label mixup with Isosorbide Mononitrate.

    Product
    RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-807-2014·2014-01-29

    Aidapak Recalls Phenytoin Sodium ER Capsules Due to Labeling Error

    Aidapak Services is recalling Phenytoin Sodium ER capsules because they may have been mislabeled as Lithium Carbonate ER tablets.

    Product
    PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071374066.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1015-2014·2014-01-29

    FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acyclovir or trimethobenzamide. The error occurred during repacking in four western states.

    Product
    chlorproMAZINE HCl, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030300.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-905-2014·2014-01-29

    Temazepam Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Temazepam 7.5 mg capsules because they may be mislabeled as Calcium Citrate or Valsartan.

    Product
    TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378311001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-843-2014·2014-01-29

    Aidapak Recalls Mislabeled Amlodipine Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling 5 mg amlodipine besylate tablets that may have been mislabeled as cyanocobalamin. The error involves a label mixup affecting specific lots.

    Product
    amLODIPine BESYLATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093716798.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-997-2014·2014-01-29

    FDA Recalls Trifluoperazine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Trifluoperazine HCL tablets because they may have been mislabeled as Terbutaline Sulfate.

    Product
    TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781103001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1023-2014·2014-01-29

    Aidapak Recalls Niacin TR Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Niacin TR capsules because they may have been mislabeled as Methylergonovine Maleate tablets.

    Product
    NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-967-2014·2014-01-29

    Aidapak Recalls Dicyclomine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Dicyclomine HCL 20 mg tablets because they may have been mislabeled as Ramipril 2.5 mg capsules.

    Product
    DICYCLOMINE HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591079501.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0799-2014·2014-01-29

    Zeiss Compensator Slider Lambda 6x20 Recalled for Misalignment

    Carl Zeiss Microscopy is recalling the Compensator Slider Lambda 6x20 component due to misalignment of the lambda plate.

    Product
    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-994-2014·2014-01-29

    Sulfasalazine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 500 mg sulfasalazine tablets that may be mislabeled as fluconazole or phenytoin sodium.

    Product
    sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-874-2014·2014-01-29

    Omega-3 Acid Ethyl Esters Capsules Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Omega-3 Acid Ethyl Esters capsules due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.

    Product
    OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-760-2014·2014-01-29

    Novartis Recalls NeoCitran DM Cough and Cold Powder Packets

    Novartis is recalling NeoCitran DM Cough & Cold powder packets because they may contain foreign substances. The products were distributed in the U.S., Canada, and other countries.

    Product
    NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-966-2014·2014-01-29

    FDA Recalls Propafenone HCL Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Propafenone HCL 150 mg tablets because they may have been mislabeled as Fosinopril Sodium 10 mg tablets.

    Product
    PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591058201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-882-2014·2014-01-29

    Aidapak Recalls Candesartan Cilexetil Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Candesartan Cilexetil 16 mg tablets because they may have been mislabeled as Irbesartan 150 mg.

    Product
    CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00186001631.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-972-2014·2014-01-29

    Aidapak Recalls Cyclobenzaprine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 5 mg cyclobenzaprine tablets because they may have been mislabeled as ascorbic acid or atenolol.

    Product
    CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-899-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Levothyroxine Sodium tablets that may have been mislabeled as Pramipexole Di-HCl.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181701
    Category
    Drug
    Distribution
    4 states