The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

26176–26200 of 32215

  • SevereFDA (Drugs)·D-975-2014·2014-01-29

    FDA Recalls Mislabeled Quinidine Sulfate Tablets Distributed by Aidapak

    Aidapak Services, LLC is recalling Quinidine Sulfate 200 mg tablets that may have been mislabeled as Quinapril 40 mg. The error occurred during repacking in four western states.

    Product
    quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591543801.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-873-2014·2014-01-29

    Dutasteride Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 0.5 mg dutasteride capsules because they may have been mislabeled as phenol, repaglinide, or cholecalciferol.

    Product
    DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071215.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-820-2014·2014-01-29

    Carbamazepine ER Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as isosorbide dinitrate or sirolimus.

    Product
    carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078051005.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-870-2014·2014-01-29

    Aidapak Recalls Anagrelide HCL Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Anagrelide HCL capsules because they may have been mislabeled as Aripiprazole tablets.

    Product
    ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172524160.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-898-2014·2014-01-29

    Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-952-2014·2014-01-29

    FDA Recalls Estradiol Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Estradiol 0.5 mg tablets because they may have been mislabeled as Nicotine Polacrilex gum.

    Product
    ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555089902.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1031-2014·2014-01-29

    KVK-Tech Recalls Hydroxyzine Hydrochloride Tablets Due to Unapproved Ingredient Source

    KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride tablets because the active pharmaceutical ingredient was sourced from an unapproved supplier.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-855-2014·2014-01-29

    FDA Recalls MEXILETINE HCL Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling MEXILETINE HCL capsules because they may have been mislabeled as CALCIUM ACETATE. The error could lead to patients receiving the wrong medication.

    Product
    MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-796-2014·2014-01-29

    Buprenorphine HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Buprenorphine HCL SL tablets due to a potential label mixup with other medications.

    Product
    BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-765-2014·2014-01-29

    Aidapak Recalls Atomoxetine Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as other psychiatric medications.

    Product
    ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-867-2014·2014-01-29

    Aidapak Recalls Doxycycline Hyclate Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Doxycycline Hyclate 100 mg capsules because they may have been mislabeled as Raloxifene HCL 60 mg tablets.

    Product
    DOXYCYCLINE HYCLATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143314250.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-815-2014·2014-01-29

    FDA Recalls Valsartan Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Valsartan 80 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-841-2014·2014-01-29

    Simvastatin Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Simvastatin 5 mg tablets that may be mislabeled as Losartan Potassium 25 mg.

    Product
    SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715298.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-879-2014·2014-01-29

    Aidapak Recalls Lovastatin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 20 mg Lovastatin tablets because they may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185007201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-795-2014·2014-01-29

    Aidapak Recalls Acarbose Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Acarbose 25 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-993-2014·2014-01-29

    FDA Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.

    Product
    PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-892-2014·2014-01-29

    Thioridazine HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services, LLC is recalling Thioridazine HCL 50 mg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.

    Product
    THIORIDAZINE HCL, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378061601.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-960-2014·2014-01-29

    Aidapak Recalls Lorazepam Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Lorazepam tablets that may have been mislabeled as Tramadol HCl. The repacked drugs were distributed in four western states.

    Product
    LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591024001.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-850-2014·2014-01-29

    Aidapak Recalls Glyburide Tablets Due to Potential Label Mixup

    Aidapak Services is recalling glyBURIDE MICRONIZED tablets because they may have been mislabeled as digoxin. The error could lead to patients receiving the wrong medication.

    Product
    glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093803501.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1006-2014·2014-01-29

    Tacrolimus Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 0.5 mg tacrolimus capsules because they may have been mislabeled as cinacalcet or isosorbide mononitrate.

    Product
    TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1034-2014·2014-01-29

    Fresenius Kabi Recalls Tranexamic Acid Injection Due to Particulate Matter

    Fresenius Kabi USA is recalling 121,456 vials of Tranexamic Acid Injection USP due to the presence of particulate matter consistent with glass vial delamination.

    Product
    Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-844-2014·2014-01-29

    Losartan Potassium Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Losartan Potassium 25 mg tablets because they may have been mislabeled as Phytonadione 5 mg.

    Product
    LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093736498.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-961-2014·2014-01-29

    Aidapak Recalls Loxapine Capsules Due to Potential Sertraline Labeling Error

    Aidapak Services, LLC is recalling Loxapine 5 mg capsules that may have been mislabeled as Sertraline HCL 50 mg tablets. The repacked drugs were distributed in four western states.

    Product
    LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-800-2014·2014-01-29

    FDA Recalls Efavirenz Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Efavirenz 200 mg capsules because they may have been mislabeled as metformin HCl 500 mg tablets.

    Product
    EFAVIRENZ, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00056047492.
    Category
    Drug
    Distribution
    4 states