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.

26251–26275 of 32215

  • SevereFDA (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-494-2014·2014-01-22

    FDA Recalls Melatonin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 1 mg melatonin tablets that may be mislabeled as quetiapine fumarate or docusate sodium.

    Product
    MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-420-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Fluconazole and Gentamicin Solution

    Specialty Medicine Compounding Pharmacy is recalling fluconazole and gentamicin solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-510-2014·2014-01-22

    Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets

    Aidapak Services, LLC is recalling 20 mg pantoprazole sodium tablets that may be mislabeled as nortriptyline hydrochloride capsules.

    Product
    PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-544-2014·2014-01-22

    Quinapril Tablets Recalled for Potential Mislabeling as Propranolol HCL

    Aidapak Services, LLC is recalling Quinapril 40 mg tablets that may be mislabeled as Propranolol HCL 10 mg. The error involves a label mixup on repacked drugs.

    Product
    QUINAPRIL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722027090
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-736-2014·2014-01-22

    Sigma-Tau Recalls Oncaspar Injection Due to Sterility Concerns

    Sigma-Tau Pharmaceuticals is voluntarily recalling five lots of Oncaspar Injection because a crack under the crimp seal caused a leak, compromising sterility.

    Product
    PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-600-2014·2014-01-22

    Aidapak Recalls Clomipramine Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Clomipramine HCl capsules because they may be mislabeled as other prescription medications.

    Product
    clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-521-2014·2014-01-22

    Pramipexole Tablets Recalled for Potential Label Mixup with Tacrolimus

    Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Tacrolimus capsules. The error could lead to patients taking the wrong medication.

    Product
    PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-641-2014·2014-01-22

    FDA Recalls Mislabeled Darunavir Tablets Distributed by Aidapak Services

    Aidapak Services is recalling Darunavir tablets that may be mislabeled as Hydrocodone/Acetaminophen. The error could lead to incorrect medication administration.

    Product
    DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1413-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Coho Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Teriyaki Smoked Coho Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: "***BIG BLUE FISHERIES, LLC***Teriyaki Smoked Coho Salmon***Ingredients…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-606-2014·2014-01-22

    Aidapak Recalls Prenatal Multivitamin Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling prenatal multivitamin tablets that may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991056601
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-613-2014·2014-01-22

    Mesalamine CR Capsules Recalled for Potential Label Mixup with Aspirin

    Aidapak Services is recalling Mesalamine CR capsules that may be mislabeled as Aspirin EC tablets due to a labeling error.

    Product
    MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1337-2014·2014-01-22

    Jensen's Recalls Hot Smoked Salmon Due to Labeling and Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Savory Hot Smoked Salmon because it is not consistently labeled 'KEEP FROZEN' and has the potential to be contaminated with Clostridium botulinum.

    Product
    Savory Hot Smoked Salmon is Farmed Raised product, Low salt, vacuum packaged. Savory Smoked Salmon produced by Jensen's Smokehouse is not sold as a vacuum packaged product to the consumer. Products are shipped with "Keep Frozen" sticker on a case label. The case label…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-459-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found non-sterile.

    Product
    DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1397-2014·2014-01-22

    Jensen's Alaska King Salmon Garlic Pepper Hot Smoked Salmon Recall

    Jensen's Old Fashioned Smokehouse is recalling Garlic Pepper Hot Smoked Salmon due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Low salt, vacuum packaged, Garlic Pepper Hot Smoked Salmon with Hardwood. AKS (Alaska King Salmon) product is labeled in parts: "***Garlic Pepper Smoked Salmon product ***GARLIC PEPPER SMOKED SALMON ***INGREDIENTS: SALMON, SALT, BROWN SUGAR, GARLIC, PEPPER, HARDWOOD…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-519-2014·2014-01-22

    Finasteride Tablets Recalled for Potential Mislabeling as Other Medications

    Aidapak Services is recalling Finasteride 5 mg tablets that may be mislabeled as Digoxin or Phytonadione. The error poses a risk of incorrect medication administration.

    Product
    FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714052201
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-429-2014·2014-01-22

    Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.

    Product
    Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1414-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked salmon products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Smoked Wild Silver (Coho) Salmon Filet is sold in vacuum packed plastic packages, net weight from 1 lb. to 2.5 lbs., with label located on the front that include the pack date and AK 604. NO label was provided.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-722-2014·2014-01-22

    FDA Recalls Mislabeled bupropion HCl ER Tablets

    Aidapak Services, LLC is recalling bupropion HCl ER tablets that may be mislabeled as mesalamine CR capsules due to a labeling mixup.

    Product
    buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-721-2014·2014-01-22

    Aidapak Recalls Docusate Sodium Capsules Due to Labeling Mixup

    Aidapak Services, LLC is recalling Docusate Sodium capsules because they may be mislabeled as other medications. The affected products were distributed in four western states.

    Product
    DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-714-2014·2014-01-22

    Colesevelam HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Colesevelam HCL tablets that may be mislabeled as lamoTRIgine due to a labeling error.

    Product
    COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-427-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Hydroxocobalamin/Thiamine Injectable

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.

    Product
    HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1409-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked King Salmon Bellies Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Smoked King Salmon Bellies is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: "***BIG BLUE FISHERIES, LLC***Smoked King Salmon Bellies***Ingredients: Wild…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-579-2014·2014-01-22

    Aidapak Recalls Lactobacillus GG Capsules Due to Labeling Mixup

    Aidapak Services is recalling Lactobillus GG capsules because they may be mislabeled as other medications, including Tacrolimus.

    Product
    LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states