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.

27926–27950 of 32242

  • SevereFDA (Devices)·Z-1698-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 30 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-723-2013·2013-07-17

    Olympia Pharmacy Recalls Diphenhydramine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Diphenhydramine 50 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-722-2013·2013-07-17

    Olympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Diclazuril 10 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-763-2013·2013-07-17

    Olympia Pharmacy Recalls Neomycin Polymyxin Dexamethasone Ophthalmic Drops

    Olympia Pharmacy is recalling compounded ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-782-2013·2013-07-17

    Olympia Pharmacy Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling specific lots of compounded Sodium Tetradecyl Sulfate injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-693-2013·2013-07-17

    Olympia Pharmacy Recalls Acepromazine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Acepromazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-739-2013·2013-07-17

    Olympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling HACC 270.1 Injection because FDA inspection findings raised concerns about quality control processes and the assurance of sterility.

    Product
    HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-752-2013·2013-07-17

    Olympia Pharmacy Recalls Meloxicam Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Meloxicam 5 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-750-2013·2013-07-17

    Olympia Pharmacy Recalls Medetomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Medetomidine 2 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-736-2013·2013-07-17

    FDA Recalls Compounded Glutathione Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Glutathione 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1608-2013·2013-07-17

    GHSW LLC Recalls Mango Spears for Potential Salmonella Contamination

    GHSW, LLC is recalling Garden Highway and Winn-Dixie brand mango spears in Florida, Louisiana, and Texas due to potential Salmonella contamination.

    Product
    Mango Spears: 1) Garden Highway Fresh Fruit Perishable Keep Refrigerated Mango Spears Net Wt 1 LB (454g) Renaissance Food Group LLC ,Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Mango Packed in its own juice; UPC: 826766268498 2) Mango Spears 1 lb (454g)…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1604-2013·2013-07-17

    Finger Lakes Farmstead Bier Meck Gouda Recalled for Listeria

    Finger Lakes Farmstead Cheese Company is recalling 7 wheels of Bier Meck Gouda due to Listeria monocytogenes contamination.

    Product
    Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-698-2013·2013-07-17

    Aminocaproic Acid Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Aminocaproic Acid 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-769-2013·2013-07-17

    Olympia Pharmacy Recalls Phenobarbital Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Phenobarbital 62.5 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-757-2013·2013-07-17

    Olympia Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of compounded Methylcobalamin injections nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-713-2013·2013-07-17

    Olympia Pharmacy Recalls Chlorpromazine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of compounded Chlorpromazine HCL 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-762-2013·2013-07-17

    Olympia Pharmacy Recalls Naproxen Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Naproxen 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-776-2013·2013-07-17

    Olympia Pharmacy Recalls Compounded Progesterone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Progesterone 100 mg/ml in Olive Oil Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V314000·2013-07-16

    Lotus Recalls 2011 Evora Vehicles Due to Oil Hose Chafing Risk

    Lotus is recalling 80 model year 2011 Evora supercharged vehicles with manual transmissions because the engine oil cooler hose may chafe and rupture, leading to oil loss.

    Product
    LOTUS — LOTUS EVORA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V312000·2013-07-16

    Suzuki Recalls 2013 Hayabusa Motorcycles Due to ABS Malfunction

    Suzuki is recalling 2,561 model year 2013 GSX1300RA Hayabusa motorcycles because a manufacturing error may cause the Anti-Lock Brake System to malfunction, increasing crash risk.

    Product
    SUZUKI — SUZUKI HAYABUSA GSX1300RA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-650-2013·2013-07-10

    Latanoprost eye drops recalled due to sterility concerns

    Clinical Specialties Compounding Pharmacy is recalling Latanoprost 0.025% eye drops because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-627-2013·2013-07-10

    Baxter Recalls Lidocaine Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of Lidocaine Hydrochloride and 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.

    Product
    Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-648-2013·2013-07-10

    Itraconazole 1% Eye Ointment Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Itraconazole 1% eye ointment because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states