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.

26301–26325 of 32215

  • SevereFDA (Drugs)·D-697-2014·2014-01-22

    Aidapak Recalls Lubiprostone Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Lubiprostone capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-689-2014·2014-01-22

    Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets

    Aidapak Services, LLC is recalling 20 mg Pantoprazole Sodium tablets that may be mislabeled as Fosinopril Sodium. The error involves a label mixup on repacked drugs.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-711-2014·2014-01-22

    Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling guanfacine HCl tablets because they may be mislabeled as other prescription medications.

    Product
    guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-511-2014·2014-01-22

    FDA Recalls Potentially Mislabeled Losartan Potassium Tablets

    Aidapak Services is recalling Losartan Potassium tablets that may be mislabeled as Disopyramide Phosphate. The error involves a label mixup on repacked drugs.

    Product
    LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668011390
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-596-2014·2014-01-22

    Rivaroxaban Tablets Recalled for Potential Venlafaxine Labeling Error

    Aidapak Services is recalling Rivaroxaban 20 mg tablets that may be mislabeled as Venlafaxine HCL 100 mg due to a label mixup.

    Product
    RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50458057930
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1420-2014·2014-01-22

    Glass Onion Catering Recalls Delish Vegetarian Wraps Due to E. coli Outbreak

    Atherstone Foods Inc dba Glass Onion Catering is recalling Delish Vegetarian Wraps because an investigation linked the company to an outbreak of E. coli O157:H7.

    Product
    Delish Vegetarian Wrap, Fire Roasted red bell pepper tortilla with tender mixed greens, fresh carrots, cucumber, Jicama, sundried tomatoes, couscous & ages asiago cheese with a side of sweet basil dressing. 11.3 oz, (322 g)) wrapped in cellophane. Packaged for Walgreens…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-568-2014·2014-01-22

    FDA Recalls Fexofenadine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling Fexofenadine HCl tablets that may be mislabeled as Pyridoxine, Niacin, or Cranberry Extract.

    Product
    FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-413-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Ceftazidime Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Ceftazidime ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-418-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls EDETATE DISODIUM Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling EDETATE DISODIUM ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-432-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Multitrace-4 Pediatric Injection

    Specialty Medicine Compounding Pharmacy is recalling Multitrace-4 pediatric injections because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-478-2014·2014-01-22

    Aidapak Recalls Prenatal Multivitamin Tablets Due to Labeling Errors

    Aidapak Services, LLC is recalling prenatal multivitamin tablets that may be mislabeled as other medications like riluzole or aspirin.

    Product
    PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904531360
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-426-2014·2014-01-22

    Hydroxocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin 10,000 mcg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1395-2014·2014-01-22

    Jensen's Recalls Hot Smoked Sockeye Salmon for Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling 3,446 lbs of hot smoked sockeye salmon in Washington due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Hot Smoked Alaskan Sockeye Salmon is a low salt, vacuum packaged. Great Ruby Fish Co Sockeye Hot smoked salmon has no labels. ROLF'S Choice Sockeye Salmon is labeled in parts: "***ROLF'S CHOICE***SMOKED ALASKAN SOCKEYE SALMON*** Ingredients: salmon, salt, brown sugar…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-514-2014·2014-01-22

    Aidapak Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets that may be mislabeled as Pioglitazone HCL 15 mg. The repacked drugs were distributed in four western states.

    Product
    PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714002104
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-454-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Vancomycin Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution because sterility cannot be assured. The product was distributed to healthcare providers and patients in Michigan.

    Product
    VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2012-2014·2014-01-22

    Big Blue Fisheries Recalls Pepper Smoked Coho Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products, including Pepper Smoked Coho Salmon, because they may not have been properly cooked and could be contaminated with Clostridium botulinum.

    Product
    Pepper 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***Pepper Smoked Coho Salmon***Ingredients: Wild…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1415-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Black Cod Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products, including hickory smoked black cod, because they may not have been properly cooked and could be contaminated with Clostridium botulinum.

    Product
    Hickory Smoked Black Cod 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***Hickory Smoked Black Cod***Ingredients: Wild…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-434-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable

    Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-453-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Triple Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1422-2014·2014-01-22

    Glass Onion Catering Recalls Southwestern Salad Kits Due to E. coli Outbreak

    Atherstone Foods Inc dba Glass Onion Catering is recalling Southwestern Salad kits because an investigation linked the supplier to an E. coli O157:H7 outbreak.

    Product
    Southwestern Salad kit (20 lb box). Contents in individual Bags: Cooked Soo Foo Roasted Corn Red and Yellow Bell Peppers Jalapenos Cilantro Pepitas Dressing. Packaged for Whole Foods Manufactured by Glass Onion Catering, Richmond, CA
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-440-2014·2014-01-22

    Polidocanol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-473-2014·2014-01-22

    FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling calcium citrate tablets that may be mislabeled as trimethobenzamide HCL capsules.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-720-2014·2014-01-22

    Aidapak Recalls Selegiline HCL Capsules Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Selegiline HCL 5 mg capsules because they may be mislabeled as Itraconazole 100 mg. The repacked drugs were distributed in four western states.

    Product
    SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1392-2014·2014-01-22

    Jensen's Recalls Teriyaki Salmon for Missing Frozen Label and Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Alaska King Seafoods Short Strips Teriyaki salmon because it lacks a 'KEEP FROZEN' label, creating a potential risk of Clostridium botulinum contamination.

    Product
    Short Strips Teriyaki is a low salt, vacuum packaged, Hot Smoked Salmon, and it is sold under Alaska King Seafoods brand. The labels contain the following statement above or below the product name and/or ingredient statement: "***IMPORTANT KEEP FROZEN***THAW UNDER…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-422-2014·2014-01-22

    Gatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state