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.

27001–27025 of 32219

  • SevereFDA (Drugs)·D-294-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Cypionate Vials

    Main Street Compounding Pharmacy is recalling Testosterone Cypionate 300mg/ml vials due to adverse reactions reported for a different compounded product.

    Product
    Testosterone Cypionate 300mg/ml, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0483-2014·2013-12-11

    Garden-Fresh Recalls Potato Salad Due to Listeria Contamination Risk

    Garden-Fresh Foods is recalling specific varieties of red potato salad because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Red Potato Salad, Product Code 0 11596 24205 7, 8/2 lb. Weis Red Potato Salad, Product Code 0 41497 05848 8, 6/16 oz. .
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0633-2014·2013-12-11

    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 Watergate Salad, Product Code 0 11596 85086 3 10/31/2013 - 11/28/2013 1/8 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-051-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls B-Complex Injection Due to Adverse Reactions

    Main Street Family Pharmacy is recalling B-Complex 206 mg/ml 30ml vials after reports of skin abscesses linked to a different compounded product.

    Product
    B-Complex 206 mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0670-2014·2013-12-11

    Garden-Fresh Foods 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
    Spoon River Buttermilk Ranch Dip, Product Code 0 11596 55685 7, 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-088-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Estradiol Pellet 50mg units after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Estradiol Pellet 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-059-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone 7mg Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Betamethasone 7mg after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Betamethasone 7mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-267-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls PGE1 Due to Skin Abscess Reports

    Main Street Family Pharmacy is recalling Single Strength PGE1 20mcg/ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Single Strength PGE1 20mcg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-265-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sermorelin 3mg Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 71 units of Sermorelin 3mg after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-249-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Mitomycin 40mg Compounded Vials

    Main Street Compounding Pharmacy is recalling 10 units of Mitomycin 40mg Compounded due to reports of skin abscesses.

    Product
    Mitomycin 40mg Compounded, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-156-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Let Gel Due to Skin Abscess Reports

    Main Street Family Pharmacy is recalling Let Gel after seven reports of skin abscesses potentially linked to the product.

    Product
    Let Gel, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-232-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Mic B-Complex Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Mic B-Complex 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Mic B-Complex 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-045-2014·2013-12-11

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

    Main Street Family Pharmacy is recalling 15 units of B-12 1ml prefilled syringes after receiving seven reports of skin abscesses linked to a different compounded product.

    Product
    B-12 1ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-124-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 250 iu Prefilled Syringes

    Main Street Family Pharmacy, LLC is recalling HCG 250 iu prefilled syringes due to adverse reactions reported for a different compounded product.

    Product
    HCG 250 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-071-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Dexamethasone LA Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Dexamethasone LA 16mg/ml 10ml vials after reports of skin abscesses linked to a related compounded product.

    Product
    Dexamethasone LA 16mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-194-2014·2013-12-11

    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
    Marcaine .1%/NS 400ml-pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-175-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotonix Plus Due to Skin Abscesses

    Main Street Family Pharmacy is recalling Lipotonix Plus 10ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Lipotonix Plus 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-283-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Vials Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 62 vials of Testosterone Cypionate/Propionate after receiving seven reports of skin abscesses.

    Product
    Testosterone Cypionate/Propionate 250mg/ml 10ml via, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0523-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat Salads Due to Listeria Contamination 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 Italian Market Salad Kit, Product Code 0 11596 62208 8 , 1/5.12lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-112-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 1500iu PFS Vials

    Main Street Compounding Pharmacy is recalling HCG 1500iu PFS vials due to reports of skin abscesses linked to a different compounded product.

    Product
    HCG 1500iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0577-2014·2013-12-11

    Garden-Fresh Foods 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
    D'Amico & Sons Smoked Paprika Rouille,Product Code 0 00 85239 10012 7 11/3/2013 - 11/8/2013 6/14 oz
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0437-2014·2013-12-11

    Siemens Oncor Linear Accelerators Recalled for Dark Current Radiation Risk

    Siemens is recalling three Oncor Linear Accelerator units due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ONCOR series 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-113-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG Syringes Due to Adverse Reaction Reports

    Main Street Family Pharmacy is recalling HCG 175 iu prefilled syringes after receiving reports of skin abscesses potentially linked to the product.

    Product
    HCG 175 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-281-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Test Cypionate Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Test Cypionate 20mg/ml 5ml vials after receiving seven reports of skin abscesses.

    Product
    Test Cypionate 20mg/ml 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-060-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone 9mg Due to Skin Abscesses

    Main Street Family Pharmacy is recalling 12 units of Betamethasone 9mg after seven reports of skin abscesses potentially linked to the product.

    Product
    Betamethasone 9mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide