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.

26151–26175 of 32215

  • SevereFDA (Drugs)·D-989-2014·2014-01-29

    Aidapak Recalls Perphenazine Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Perphenazine 16 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-764-2014·2014-01-29

    Cubicin Injection Recalled for Glass Particulates in Vials

    Cubist Pharmaceuticals is recalling 179,870 vials of Cubicin (daptomycin for injection) due to the presence of glass particulates.

    Product
    Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-887-2014·2014-01-29

    Aidapak Recalls Rosuvastatin Calcium Tablets Due to Labeling Error

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

    Product
    ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1022-2014·2014-01-29

    Aidapak Recalls Thiamine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Thiamine HCL 100 mg tablets because they may have been mislabeled as other drugs, including simvastatin and buprenorphine.

    Product
    THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904054460.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-981-2014·2014-01-29

    FDA Recalls Bismuth Subsalicylate Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Bismuth Subsalicylate chewable tablets that may have been mislabeled as Irbesartan. The error could lead to patients taking the wrong medication.

    Product
    BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1014-2014·2014-01-29

    FDA Recalls Chlorpromazine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling chlorpromazine HCl tablets that may be mislabeled as acamprosate calcium. The error could lead to patients receiving the wrong medication.

    Product
    chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030200.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-977-2014·2014-01-29

    Minoxidil Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Minoxidil 2.5 mg tablets because they may have been mislabeled as methylprednisolone 4 mg.

    Product
    MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591564201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-854-2014·2014-01-29

    Aidapak Recalls Mislabeled glyBURIDE Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling glyBURIDE tablets that may have been mislabeled as other prescription drugs. The error poses a risk of patients receiving incorrect medication.

    Product
    glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-998-2014·2014-01-29

    FDA Recalls Perphenazine Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 16 mg Perphenazine tablets because they may have been mislabeled as other prescription drugs.

    Product
    PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781104901.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1019-2014·2014-01-29

    Aidapak Recalls Ascorbic Acid Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 500 mg Ascorbic Acid tablets because they may have been mislabeled as Venlafaxine HCL 100 mg.

    Product
    ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052372.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0789-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2014·2014-01-29

    Aidapak Recalls Mislabeled Methylprednisolone Tablets

    Aidapak Services, LLC is recalling methylprednisolone tablets that may have been mislabeled as levothyroxine, nabumetone, or cholecalciferol.

    Product
    methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-826-2014·2014-01-29

    FDA Recalls Piroxicam Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 10 mg Piroxicam capsules because they may have been mislabeled as Hyoscyamine Sulfate. The error could lead to patients receiving the wrong medication.

    Product
    PIROXICAM, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093075601.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1026-2014·2014-01-29

    Aidapak Recalls Tri-Buffered Aspirin Tablets Due to Labeling Error

    Aidapak Services is recalling Tri-Buffered Aspirin tablets because they may have been mislabeled as a different medication. The error involves a potential mix-up with Isometheptene Mucate/Dichlorphenazone/APAP capsules.

    Product
    TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-992-2014·2014-01-29

    FDA Recalls Phenobarbital Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Phenobarbital tablets that may have been mislabeled as Efavirenz capsules. The error involves a label mixup during repacking.

    Product
    PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1024-2014·2014-01-29

    Aidapak Recalls Niacin TR Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Niacin TR capsules because they may have been mislabeled as other drugs like Perphenazine or Melatonin.

    Product
    NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-978-2014·2014-01-29

    Aidapak Recalls Minocycline Capsules Due to Potential Labeling Error

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

    Product
    MINOCYCLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569401.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1033-2014·2014-01-29

    Hospira Recalls Propofol Vials Due to Glass Particulate Matter

    Hospira is recalling 126,425 vials of Propofol Injectable Emulsion due to a glass defect that could release particulate matter into the solution.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-861-2014·2014-01-29

    Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup

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

    Product
    DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-903-2014·2014-01-29

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Potential Label Mixup

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

    Product
    ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-982-2014·2014-01-29

    FDA Recalls Mislabeled Acetaminophen, Butalbital, and Caffeine Tablets

    Aidapak Services, LLC is recalling Acetaminophen/Butalbital/Caffeine tablets that may have been mislabeled as Aspirin. The error could cause patients to take the wrong medication.

    Product
    ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603254421.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-990-2014·2014-01-29

    FDA Recalls Phenobarbital Tablets Due to Potential Pregabalin Labeling Error

    Aidapak Services is recalling Phenobarbital tablets that may be mislabeled as Pregabalin capsules. The error poses a risk of patients receiving the wrong medication.

    Product
    PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1438-2014·2014-01-29

    Giant Eagle Recalls Candy Place Chocolate Santas Due to Undeclared Peanut Allergen

    Giant Eagle is recalling Candy Place Chocolate Santas because the peanut allergen is not declared on the primary label and the caramel variety ingredient statement is missing.

    Product
    Candy Place Chocolate Santas, in 11 oz clear plastic bags, individually wrapped assortment of double chocolate, caramel, and peanut butter flavored chocolates, distributed by Giant Eagle, Pittsburgh, PA. Ingredients: Sugar, partially hydrogenated vegetable oil (Palm kernel…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-897-2014·2014-01-29

    Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as other prescription drugs.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
    Category
    Drug
    Distribution
    4 states