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.

27051–27075 of 32219

  • SevereFDA (Drugs)·D-218-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

    Main Street Compounding Pharmacy is recalling methylprednisolone vials after seven reports of skin abscesses. The affected products were distributed nationwide.

    Product
    Methylprednisolone 40mg w/lidocaine 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-044-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls B-12 Syringes Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 116 units of B-12 prefilled syringes following reports of skin abscesses linked to a related compounded product.

    Product
    B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0728-2014·2013-12-11

    Oma's Choice Habanero Chunk Pickles Recalled for Process Authority Evaluation

    Oma's Choice Inc is recalling Habanero Chunk Pickles because the products were not submitted to a process authority for evaluation.

    Product
    Oma's Choice, Habanero Chunk Pickles, Net Wt 32 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-192-2014·2013-12-11

    Main Street Family Pharmacy Recalls Compounded Methylprednisolone Vials

    Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to reports of skin abscesses.

    Product
    MALE HCG PK 3rd month (320, 330,340, 350iu) Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-252-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Oral B-12 Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Oral B-12 30ml cotton candy flavor after reports of skin abscesses linked to a related compounded product.

    Product
    Oral B-12 30ml--cotton candy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0573-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat Salads and Slaws Due to Listeria Risk

    Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Poppy Seed Cole Slaw, Product Code 0 11596 83016 2 10/31/2013 - 11/20/2013 1/8 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-253-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

    Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials after seven reports of skin abscesses.

    Product
    Phosphatidylcholine/Deoxycholic Acid 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0528-2014·2013-12-11

    Garden-Fresh Recalls Greek Style Pasta Salad Due to Listeria Risk

    Garden-Fresh Foods is recalling Greek Style Pasta Salad and other ready-to-eat products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Greek Style Pasta Salad,Product Code 0 11596 52035 3 ,1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-290-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Cypionate w/lidocaine 10ml Vials

    Main Street Family Pharmacy, LLC is recalling 20 units of Testosterone Cypionate w/lidocaine 10ml due to reports of skin abscesses linked to a different compounded product.

    Product
    Testosterone Cypionate w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0567-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat Salads and Slaw Due to Listeria Risk

    Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Amish Country Cole Slaw, Product Code 0 11596 53010 9 11/4/2013 - 11/15/2013 2/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0667-2014·2013-12-11

    Garden-Fresh Foods Recalls Fruit Dip for Listeria Contamination

    Garden-Fresh Foods is recalling Finest Traditions Fruit Dip and other ready-to-eat products because they may be contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Fruit Dip ,Product Code 7 33147 10852 9, 6/11 oz
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-066-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Calcium Gluconate Gel

    Main Street Family Pharmacy is recalling 5 units of Calcium Gluconate 2.5% Gel due to adverse reactions reported for a different compounded product.

    Product
    Calcium Gluconate 2.5% Gel, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-244-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Minoxidil 15% Due to Adverse Reactions

    Main Street Family Pharmacy, LLC is recalling Minoxidil 15% 60ml vials after receiving seven reports of skin abscesses.

    Product
    Minoxidil 15% 60ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-272-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sodium Tetradecyl Sulfate

    Main Street Family Pharmacy is recalling Sodium Tetradecyl Sulfate 5.0% 30ml vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Sodium Tetradecyl Sulfate 5.0% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-079-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Dexamethasone Sodium Phosphate

    Main Street Compounding Pharmacy is recalling dexamethasone sodium phosphate vials due to reports of skin abscesses linked to a similar compounded product.

    Product
    Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-160-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lido 4%/Phenyl 1% Due to Skin Abscesses

    Main Street Family Pharmacy is recalling Lido 4%/Phenyl 1% after seven reports of skin abscesses potentially linked to the product.

    Product
    Lido 4%/Phenyl 1%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0655-2014·2013-12-11

    Garden-Fresh Recalls Artichoke Spinach Dip Due to Listeria Risk

    Garden-Fresh Foods is recalling specific varieties of artichoke spinach dip because they may be contaminated with Listeria monocytogenes.

    Product
    Grandpas Artichoke Spinach Dip, Product Code 0 11596 55902 5, 1/5 lb; Archer Farms Artichoke Spinach Dip, Product Code 0 85239 99015 5, 6/11 oz; Archer Farms Artichoke Spinach Dip, Product Code 0 85239 69053 6, 4/18 oz; Roundy's Artichoke Spinach Dip, Product Code 0…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-245-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Mitomycin Due to Adverse Reaction Reports

    Main Street Family Pharmacy is recalling 4 units of Mitomycin 0.02% following seven reports of skin abscesses potentially linked to the product.

    Product
    Mitomycin 0.02%,2.5ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0501-2014·2013-12-11

    Garden-Fresh Foods Recalls Finest Traditions Potato Salad Due to Listeria Risk

    Garden-Fresh Foods is recalling specific varieties of Finest Traditions Deluxe Potato Salad because they may be contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Deluxe Potato Salad, Product Code 10 733147 10450 4, 4/8 lb; Finest Traditions Deluxe Potato Salad, Product Code 10 733147 10130 5, 1/8 lb; Finest Traditions Deluxe Potato Salad, Product Code 7 33147 00007 6, 6/16 oz;
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0580-2014·2013-12-11

    Garden-Fresh Foods Recalls Ready-to-Eat Salads and Slaw for Listeria Risk

    Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products because they may be contaminated with Listeria monocytogenes.

    Product
    Dairy Fresh Homemade Dixie Cole Slaw, Product Code 0 70163 55890 8,2/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-307-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Pellets Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Testosterone Pellets 75mg after receiving reports of skin abscesses linked to a different compounded product.

    Product
    Testosterone Pellets 75mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide