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.

26876–26900 of 32218

  • SevereFDA (Drugs)·D-176-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotonix Plus Due to Skin Abscesses

    Main Street Family Pharmacy is recalling Lipotonix Plus 30ml vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Lipotonix Plus 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-050-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls B-Complex 100 Due to Skin Abscesses

    Main Street Compounding Pharmacy is recalling 35 units of B-Complex 100 30ml (PF) after receiving seven reports of skin abscesses.

    Product
    B-Complex 100 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-248-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Mitomycin 40mg Due to Adverse Reactions

    Main Street Family Pharmacy, LLC is recalling 370 units of Mitomycin 40mg after receiving seven reports of skin abscesses.

    Product
    Mitomycin 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0550-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat Salads and Dips 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
    Garden-Fresh Parmesan Peppercorn Pasta Salad Base, Product Code 0 11596 52086 5, 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0705-2014·2013-12-11

    Crunch Pak Apple Slices Recalled for Listeria Contamination Risk

    Crunch Pak Honeycrisp Apple Slices are being recalled due to potential Listeria monocytogenes contamination. Consumers should check their pantries for the affected 12-ounce bags.

    Product
    Crunch Pak Honeycrisp Apple Slices, 12 ounce bag. The UPC is 7 32313 12001 3. The product is labeled in parts: "***CRUNCH PAK***apple Slices***HONEYCRISP***NET WT. 12 oz***CRUNCH PAK, LLC***CASHMERE, WA 98815***".
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Drugs)·D-212-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscesses

    Main Street Compounding Pharmacy is recalling 40 units of Methylprednisolone 20mg PF 5ml due to reports of skin abscesses.

    Product
    Methylprednisolone 20mg PF 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-321-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Compounded Methylprednisolone Vials

    Main Street Family Pharmacy is recalling compounded preservative-free methylprednisolone vials due to reports of skin abscesses.

    Product
    Wydase 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-123-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 240 iu Prefilled Syringes

    Main Street Family Pharmacy, LLC is recalling 1,976 units of HCG 240 iu prefilled syringes due to adverse reactions reported with a different compounded product.

    Product
    HCG 240 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-165-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lincomycin 300 (PF) 10ml Vials

    Main Street Family Pharmacy, LLC is recalling 1,516 units of Lincomycin 300 (PF) 10ml vials due to adverse reactions reported for a different compounded product.

    Product
    Lincomycin 300 (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-049-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Bacteriostatic Water Vials

    Main Street Family Pharmacy is recalling Bacteriostatic Water 30ml vials due to seven reports of skin abscesses linked to compounded methylprednisolone.

    Product
    Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-214-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscess Reports

    Main Street Compounding Pharmacy is recalling 166 units of compounded methylprednisolone after seven reports of skin abscesses potentially linked to the product.

    Product
    Methylprednisolone 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-247-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Mitomycin Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 32 units of Mitomycin 2ml due to seven reports of skin abscesses.

    Product
    Mitomycin 2ml (full Strength), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-064-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Brompheniramine Due to Adverse Reactions

    Main Street Family Pharmacy, LLC is recalling 415 units of Brompheniramine 10ml due to seven reports of skin abscesses.

    Product
    Brompheniramine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0502-2014·2013-12-11

    Garden-Fresh Foods Recalls Potato Salads 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
    Finest Traditions Homestyle Potato Salad, Product Code 10 733147 10452 8, 4/8 lb; Finest Traditions Homestyle Potato Salad, Product Code 10 733147 10134 3,1/8 lb; Finest Traditions Homestyle Potato Salad,Product Code 7 33147 00019 9, 6/16 oz; Acme Homestyle Potato Salad…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-065-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Calcium Gluconate Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 25 units of Calcium Gluconate 10% 50ml vials after reports of skin abscesses linked to a related compounded product.

    Product
    Calcium Gluconate 10% 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-270-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sodium Tetradecyl Sulfate

    Main Street Family Pharmacy is recalling Sodium Tetradecyl Sulfate 2.0% 30ml vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Sodium Tetradecyl Sulfate 2.0% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-115-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 20,000u Vials

    Main Street Family Pharmacy is recalling 531 units of HCG 20,000u vials due to reports of skin abscesses linked to a different compounded product.

    Product
    HCG 20,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0527-2014·2013-12-11

    Garden-Fresh Recalls Sour Cream Mac and Cheddar Due to Listeria Risk

    Garden-Fresh Foods is recalling specific varieties of Sour Cream Mac & Cheddar because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Sour Cream Mac & Cheddar,Product Code 0 11596 92031 3, 2/5 lb Dairy Fresh Sour Cream Mac & Cheddar, Product Code 0 70163 50043 3, 2/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-025-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Acetylcystein 10% Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Acetylcystein 10% 120ml vials after seven reports of skin abscesses linked to a different compounded product.

    Product
    Acetylcystein 10% 120ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-138-2014·2013-12-11

    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 seven reports of skin abscesses.

    Product
    HCG 360iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-320-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Trypan Blue 0.15% Vials

    Main Street Family Pharmacy is recalling 182 units of Trypan Blue 0.15% 1ml vials due to reports of adverse reactions linked to a related compounded product.

    Product
    Trypan Blue 0.15% 1ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0534-2014·2013-12-11

    Garden-Fresh Recalls Asiago Pasta Salad Due to Listeria Risk

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

    Product
    Garden-Fresh Asiago Pasta Salad, Product Code 0 11596 52069 8, 1/5 lb Archer Farms Asiago Pasta Salad,Product Code 0 85239 02230 6, 6/5 oz Archer Farms Asiago Pasta Salad,Product Code 0 85239 40201 6, 6/14 oz Dairy Fresh Asiago Pasta Salad, Product Code 0 70163 50041…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-174-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipoden 50ml Due to Skin Abscess Reports

    Main Street Family Pharmacy is recalling Lipoden 50ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Lipoden 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-154-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls L-Arginine Due to Adverse Reaction Reports

    Main Street Compounding Pharmacy is recalling L-Arginine 100mg/ml 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    L-Arginine 100mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide