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.

18901–18925 of 21645

  • ModerateFDA (Drugs)·D-996-2014·2014-01-29

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

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

    Product
    CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-969-2014·2014-01-29

    Aidapak Recalls Clindamycin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Clindamycin HCL capsules because they may have been mislabeled as Melatonin tablets. The repacked drugs were distributed in four western states.

    Product
    CLINDAMYCIN HCL, Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591312001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-776-2014·2014-01-29

    Montelukast Sodium Chew Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Montelukast Sodium chew tablets that may be mislabeled as Dicyclomine HCL. The error could lead to patients taking the wrong medication.

    Product
    MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-934-2014·2014-01-29

    Aidapak Recalls Docusate Calcium Capsules Due to Labeling Errors

    Aidapak Services, LLC is recalling 1,109 docusate calcium capsules because they may have been mislabeled as other medications. The affected products were distributed in four western states.

    Product
    DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-766-2014·2014-01-29

    Aidapak Recalls Duloxetine Capsules Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Duloxetine HCl DR capsules because they may be mislabeled with other medications. The repacked drugs were distributed in four western states.

    Product
    DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-908-2014·2014-01-29

    Aidapak Recalls Verapamil HCL ER Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Verapamil HCL ER capsules because they may have been mislabeled as Febuxostat tablets.

    Product
    VERAPAMIL HCL ER, Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378644001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-911-2014·2014-01-29

    Saccharomyces Boulardii Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Saccharomyces Boulardii capsules because they may have been mislabeled as other prescription drugs.

    Product
    SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-946-2014·2014-01-29

    Lactobacillus Acidophilus Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Lactobacillus Acidophilus tablets because they may have been mislabeled as Repaglinide.

    Product
    LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-816-2014·2014-01-29

    Valsartan Tablets Recalled for Potential Labeling Mixup with Other Drugs

    Aidapak Services is recalling Valsartan 160 mg tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-862-2014·2014-01-29

    Aidapak Recalls Nicotine Polacrilex Lozenges Due to Potential Labeling Errors

    Aidapak Services is recalling 2 mg nicotine polacrilex lozenges because they may have been mislabeled as other prescription drugs. The affected products were distributed in four western states.

    Product
    NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0822-2014·2014-01-29

    Puritan Bennett Ventilator Manual Labeling Correction for Oxygen Sensor Life

    Nellcor Puritan Bennett is correcting operator and service manuals for PB700 and PB840 ventilators to clarify the operational life of the oxygen sensor.

    Product
    Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-752-2014·2014-01-29

    Theraflu Cold Powder Recalled for Potential Foreign Substances

    Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets because they may contain foreign substances.

    Product
    THERAFLU — THERAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-775-2014·2014-01-29

    Aidapak Recalls Raltegravir Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Raltegravir 400 mg tablets because they may be mislabeled as other medications. The recall covers specific lots distributed in four western states.

    Product
    RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-808-2014·2014-01-29

    Aidapak Recalls Niacin ER Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin ER 500 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-774-2014·2014-01-29

    SitaGLIPtin Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling sitaGLIPtin phosphate tablets because they may be mislabeled as Lactobacillus or Cyanocobalamin.

    Product
    sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006011231.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-971-2014·2014-01-29

    Aidapak Recalls Pioglitazone Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 15 mg Pioglitazone tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591320530.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-917-2014·2014-01-29

    Aidapak Recalls Potassium Acid Phosphate Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Potassium Acid Phosphate 500 mg tablets because they may have been mislabeled as Prednisone 20 mg.

    Product
    POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00486111101.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-767-2014·2014-01-29

    Aidapak Recalls Atomoxetine Capsules Due to Potential Lovastatin Label Mixup

    Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as Lovastatin tablets. The repacked drugs were distributed in four western states.

    Product
    ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-877-2014·2014-01-29

    Midodrine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Midodrine HCL 2.5 mg tablets that may have been mislabeled as Pioglitazone HCL 15 mg.

    Product
    MIDODRINE HCL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185004001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-904-2014·2014-01-29

    Mycophenolate Mofetil Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Mycophenolate Mofetil capsules that may have been mislabeled as Pramipexole Di-HCl tablets.

    Product
    MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378225001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-915-2014·2014-01-29

    Aidapak Recalls Nebivolol Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Nebivolol HCL 5 mg tablets because they may have been mislabeled as Thyroid or Rasagiline Mesylate.

    Product
    NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1010-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Levothyroxine Sodium tablets that may have been mislabeled as Omega-3 Fatty Acid capsules.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781519192.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-834-2014·2014-01-29

    Sotalol HCL Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Sotalol HCL 160 mg tablets that may have been mislabeled as Disulfiram 250 mg.

    Product
    SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-991-2014·2014-01-29

    Aidapak Recalls Phenobarbital Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Phenobarbital 97.2 mg tablets because they may have been mislabeled as 64.8 mg tablets.

    Product
    PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-837-2014·2014-01-29

    Aidapak Recalls Bumetanide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Bumetanide 0.5 mg tablets because they may have been mislabeled as Erythromycin DR EC 250 mg.

    Product
    BUMETANIDE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093423201.
    Category
    Drug
    Distribution
    4 states