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.

26976–27000 of 32219

  • SevereFDA (Drugs)·D-098-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Glutathione Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Glutathione 150mg/ml 30ml vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Glutathione 150mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-104-2014·2013-12-11

    FDA Recalls Compounded HCG 10000u Due to Adverse Skin Reactions

    Main Street Family Pharmacy is recalling HCG 10000u vials after reports of skin abscesses linked to compounded methylprednisolone.

    Product
    HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0627-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat 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
    Garden-Fresh Wisconsin Cheddar & Pea Salad, Product Code 0 11596 52021 6 11/1/2013 - 11/15/2013 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0438-2014·2013-12-11

    Siemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk

    Siemens is recalling 26 ARTISTE Linear Accelerator systems due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-140-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG Syringes Due to Adverse Reactions

    Main Street Family Pharmacy is recalling HCG 380 iu prefilled syringes after reports of skin abscesses linked to a related compounded product.

    Product
    HCG 380 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0674-2014·2013-12-11

    Garden-Fresh Recalls Creamy Cole Slaw Dressing Due to Listeria Risk

    Garden-Fresh Foods is recalling Creamy Cole Slaw Dressing and other ready-to-eat products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Creamy Cole Slaw Dressing, 0 11596 43200 7, 4/2 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-289-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Cypionate Vials

    Main Street Family Pharmacy is recalling 21 units of Testosterone Cypionate 250mg 10ml vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Testosterone Cypionate 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-145-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 5,000U Vials

    Main Street Family Pharmacy is recalling HCG 5,000U vials due to reports of skin abscesses linked to a different compounded product.

    Product
    HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-293-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Cypionate Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 60 units of Testosterone Cypionate 210mg 10ml after receiving seven reports of skin abscesses.

    Product
    Testosterone Cypionate 210mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-703-2014·2013-12-11

    Allergy Research Group Sugar Balance Formula Recalled for Chloramphenicol Contamination

    Allergy Research Group is recalling Sugar Balance Formula dietary supplements because raw material cellulase enzymes were found to be contaminated with Chloramphenicol.

    Product
    Allergy Research Group Sugar Balance Formula, dietary Supplement, Hypoallergenic, 90 vegetarian capsules. Formulated exclusively for: Allergy Research Group; Alameda, CA 94502.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-306-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Pellets 50mg

    Main Street Family Pharmacy, LLC is recalling 701 units of Testosterone Pellets 50mg due to adverse reactions reported in connection with a separate compounded product.

    Product
    Testosterone Pellets 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0480-2014·2013-12-11

    Garden-Fresh Foods Recalls Potato Salads Due to Listeria Risk

    Garden-Fresh Foods is recalling specific ready-to-eat potato salad products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Red Potato And Herb Salad,Product Code 0 11596 91014 7, 10 lb.; Dairy Fresh Red Potato & Herb Salad,Product Code 0 70163 53370 7, 1/5 lb;
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0613-2014·2013-12-11

    Garden-Fresh Foods Recalls Ready-to-Eat 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 Krab Salad, Product Code 10 733147 10172 5 11/4/2013 - 11/11/2013 1/8 lb Dairy Fresh Krab Salad , Product Code 0 70163 41001 5, 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-150-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 7000u Due to Adverse Reactions

    Main Street Family Pharmacy is recalling HCG 7000u units after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    HCG 7000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0606-2014·2013-12-11

    Garden-Fresh Recalls Creamy Seafood Salad Due to Listeria Risk

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

    Product
    Garden-Fresh Creamy Seafood Salad , 0 11596 55124 1, 2/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-085-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Estradiol Valerate 40mg

    Main Street Family Pharmacy, LLC is recalling Estradiol Valerate 40mg due to adverse reaction reports involving skin abscesses.

    Product
    Estradiol Valerate 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-055-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone Due to Skin Abscess Reports

    Main Street Family Pharmacy, LLC is recalling Betamethasone 6mg 10ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Betamethasone 6mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-117-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 2000IU Vials

    Main Street Family Pharmacy is recalling HCG 2000IU vials due to reports of skin abscesses linked to a different compounded product.

    Product
    HCG 2000IU, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0571-2014·2013-12-11

    Garden-Fresh Recalls Vinegar and Oil Cole Slaw Due to Listeria Risk

    Garden-Fresh Foods is recalling specific varieties of Vinegar and Oil Cole Slaw because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Vinegar And Oil Cole Slaw, Product Code 0 11596 83000 1, 1/8 lb; Our Own Vinegar & Oil Cole Slaw, Product Code 0 11596 83002 5, 1/8 lb;
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-081-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Double Strength PGE1 Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Double Strength PGE1 40mcg/ml after receiving reports of skin abscesses linked to a related compounded product.

    Product
    Double Strength PGE1 40mcg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-209-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports

    Main Street Family Pharmacy is recalling 5 units of Methylcobalamin 30ml following seven reports of skin abscesses linked to a different compounded product.

    Product
    Methylcobalamin 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-083-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Compounded Methylprednisolone Vials

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

    Product
    EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide