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.

19276–19300 of 21751

  • ModerateFDA (Drugs)·D-695-2014·2014-01-22

    Aidapak Recalls Hydrocortisone Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Hydrocortisone 5 mg tablets that may be mislabeled as Orphenadrine Citrate ER or Calcium Acetate.

    Product
    HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-618-2014·2014-01-22

    Lactobacillus Acidophilus Capsules Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Lactobacillus Acidophilus capsules due to a potential labeling mixup with other medications.

    Product
    LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629011101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-534-2014·2014-01-22

    Venlafaxine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Venlafaxine HCL 50 mg tablets because they may be mislabeled as sulfasalazine 500 mg.

    Product
    VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155024801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-702-2014·2014-01-22

    Aidapak Recalls aMILoride Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling aMILoride HCl 5 mg tablets because they may be mislabeled as Propranolol HCl 10 mg or Famotidine 20 mg.

    Product
    aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-485-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling 1,199 tablets of Cholecalciferol 400 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-614-2014·2014-01-22

    Aidapak Recalls Mesalamine Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Mesalamine CR capsules because they may be mislabeled as clomipramine HCl. The repacked drugs were distributed in four western states.

    Product
    MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092019112
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-525-2014·2014-01-22

    Aidapak Recalls Hydrochlorothiazide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydrochlorothiazide 12.5 mg tablets because they may be mislabeled as Chlordiazepoxide HCl 25 mg capsules.

    Product
    HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16729018201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-690-2014·2014-01-22

    Aidapak Recalls 40 mg Pantoprazole Sodium Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 1,001 tablets of 40 mg Pantoprazole Sodium due to a potential labeling mixup with Sennosides.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043402
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-647-2014·2014-01-22

    Medroxyprogesterone Acetate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Medroxyprogesterone Acetate tablets that may be mislabeled as Hydralazine HCl.

    Product
    medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762374202
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-500-2014·2014-01-22

    Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Solifenacin Succinate.

    Product
    NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-605-2014·2014-01-22

    FDA Recalls Melatonin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 3 mg Melatonin tablets because they may be mislabeled as other medications like Docusate Sodium or Pioglitazone.

    Product
    MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-737-2014·2014-01-22

    Greenstone Recalls Nifedipine Tablets Due to Incorrect Expiration Date Labeling

    Greenstone LLC is recalling Nifedipine extended-release tablets because the package displays a 48-month expiration date instead of the correct 36-month date.

    Product
    Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2014·2014-01-22

    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 validation.

    Product
    MCA5-1SD - 1MM 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-0732-2014·2014-01-22

    Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias

    Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.

    Product
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-592-2014·2014-01-22

    Aidapak Recalls Trazodone Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Dexamethasone, Docusate Sodium, or Guanfacine.

    Product
    traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-463-2014·2014-01-22

    Aidapak Recalls Zinc Glucosate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Zinc Glucosate tablets because they may be mislabeled as Ascorbic Acid chew tablets.

    Product
    ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-476-2014·2014-01-22

    Aidapak Recalls Acetaminophen Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Acetaminophen/Aspirin/Caffeine tablets that may be mislabeled as Naproxen. The error could lead to incorrect medication use.

    Product
    ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0716-2014·2014-01-22

    Biomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error

    Biomet is recalling 52 locking cortical screws because a 3.5mmx28mm screw was incorrectly labeled as a 3.5mmx38mm screw.

    Product
    Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-466-2014·2014-01-22

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1,821 tablets of Cyanocobalamin 1000 mcg due to a potential label mixup with other medications.

    Product
    CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-651-2014·2014-01-22

    Zinc Sulfate Capsules Recalled for Potential Labeling Errors

    Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Calcium Acetate or Calcitrol due to a labeling mixup.

    Product
    ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-705-2014·2014-01-22

    Riluzole Tablets Recalled for Potential Labeling Mixup with Trazodone

    Aidapak Services, LLC is recalling Riluzole 50 mg tablets due to a labeling error where they may be mislabeled as Trazodone HCl 150 mg.

    Product
    RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-563-2014·2014-01-22

    Aidapak Recalls Methylergonovine Maleate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Methylergonovine Maleate tablets because they may be mislabeled as Isosorbide Mononitrate or Levothyroxine Sodium.

    Product
    METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-657-2014·2014-01-22

    Fosinopril Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 10 mg Fosinopril Sodium tablets that may be mislabeled as Calcitriol capsules due to a labeling mixup.

    Product
    FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251002
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-552-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Vitamin B Complex Prolonged Release tablets because they may be mislabeled as other medications like Coenzyme Q-10 or Aspirin.

    Product
    VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-512-2014·2014-01-22

    Aidapak Recalls Prenatal Multivitamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Prenatal Multivitamin/Multimineral tablets because they may be mislabeled as Cyanocobalamin tablets. The error involves a label mixup.

    Product
    PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 13811051410
    Category
    Drug
    Distribution
    4 states