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.

26776–26800 of 32218

  • SevereFDA (Food)·F-0408-2014·2013-12-11

    Boston Salads Recalls Tuna Salads Due to Listeria Contamination Risk

    Boston Salads & Provisions Co., Inc. is recalling specific tuna salad products due to a potential Listeria monocytogenes contamination.

    Product
    Tuna Salads- packaged in: 7 oz., 12 oz., 5 lb.10 lb and 30 lb containers Sold under the labels: Boston Salads and the Rachel's Gourmet and Dietz and Watson
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-259-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Pre-menopausal HCG Packs

    Main Street Family Pharmacy, LLC is recalling Pre-menopausal HCG packs due to adverse reactions reported with a different compounded product.

    Product
    Pre-menopausal HCG pack, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-080-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Double Strength PGE1 40mcg 2ml

    Main Street Compounding Pharmacy is recalling Double Strength PGE1 40mcg 2ml vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Double Strength PGE1 40mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-178-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotonix Plus Due to Skin Abscess Reports

    Main Street Compounding Pharmacy is recalling 59 units of Lipotonix Plus w/Proc/Chrom after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Lipotonix Plus w/Proc/Chrom, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-322-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Wydase 5ml Due to Sterility Concerns

    Main Street Family Pharmacy is recalling 50 units of Wydase 5ml because the product lacks assurance of sterility. The recall covers units distributed nationwide prior to and including May 23, 2013.

    Product
    Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-034-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls AMIC-12 with Lido 10ml Vials

    Main Street Family Pharmacy, LLC is recalling AMIC-12 with lido 10ml vials due to reports of skin abscesses.

    Product
    AMIC-12 with lido 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0623-2014·2013-12-11

    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 Seven Layer Salad Kit, Product Code 0 11596 85161 7, 2/3.25lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-032-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Alprostadil Due to Adverse Reaction Reports

    Main Street Family Pharmacy, LLC is recalling Alprostadil 20mcg/ml 25ml vials after receiving seven reports of skin abscesses.

    Product
    Alprostadil 20mcg/ml 25ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-274-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Special Mic Formula Due to Skin Abscesses

    Main Street Compounding Pharmacy is recalling Special Mic Formula 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Special Mic Formula 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-068-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Carnitine Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Carnitine 250mg/ml after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0704-2014·2013-12-11

    Crunch Pak Apple Slices Recalled for Potential Listeria Contamination

    Crunch Pak, LLC is recalling Crunch Pak Apple Slices with Low Fat Caramel Dip due to potential Listeria monocytogenes contamination. The product was distributed in 28 states.

    Product
    Crunch Pak Apple Slices with Low Fat Caramel Dip, 5/2.5 oz. Tart with Caramel Sauce. The clamshell includes 5/2 oz. bags of sliced apples and 5/ 0.5 oz. packages of caramel (sauce) dip. The UPC on the clamshell is 7 32313 09113 9. The clamshell package is labeled in parts…
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0531-2014·2013-12-11

    Garden-Fresh Recalls Sweet Bow Tie Pasta With Bacon Due to Listeria

    Garden-Fresh Foods is recalling specific varieties of Sweet Bow Tie Pasta With Bacon because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Sweet Bow Tie Pasta With Bacon,Product Code 0 11 11596 52047 2, 1/5 lb Lipari Old Tyme Sweet Bow Tie Pasta With Bacon, Product Code 0 94776 03409 3, 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0610-2014·2013-12-11

    Garden-Fresh Foods Recalls Mock Crab Salad Due to Listeria Risk

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

    Product
    Finest Traditions Mock Crab Salad, 7 33147 00027 4, 6/16 oz Finest Traditions Mock Crab Salad, 10 733147 10287 6,,1/8 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-125-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 2500u Due to Adverse Reactions

    Main Street Family Pharmacy is recalling HCG 2500u vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    HCG 2500u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-264-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sermorelin GHRP Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Sermorelin GHRP vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Sermorelin GHRP 9mg/3mg/3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0592-2014·2013-12-11

    Garden-Fresh Foods Recalls Smokey Baked Beans Due to Listeria Risk

    Garden-Fresh Foods is recalling specific varieties of Finest Traditions Smokey Baked Beans because they may be contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Smokey Baked Beans, 10 733147 10456 6, 4/8 lb Finest Traditions Smokey Baked Beans , 10 733147 10231 9, 1/8 lb Finest Traditions Smokey Baked Beans, 7 33147 00161 5, 6/16 oz
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-263-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sermorelin 6mg Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Sermorelin 6mg vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Sermorelin 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-225-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Acetate Vials

    Main Street Family Pharmacy is recalling 22 units of compounded methylprednisolone acetate vials due to reports of skin abscesses.

    Product
    Methylprednisolone Acetate 80mg 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0489-2014·2013-12-11

    Garden-Fresh Recalls German Potato Salad 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 German Potato Salad, Product Code 0 11596 91020 8, 2/5 lb.; Garden-Fresh German Potato Salad, Product Code 0 11596 14017 9, 12/16 oz.; Garden-Fresh German Potato Salad, Product Code 0 11596 34319 8, 4/3 lb. Grandpas German Potato Salad, Product Code 0 11596…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-058-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone Due to Skin Abscess Reports

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

    Product
    Betamethasone 6mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-313-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Triamcinolone PF 40mg 2ml Vials

    Main Street Family Pharmacy is recalling Triamcinolone PF 40mg 2ml vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Triamcinolone PF 40mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0707-2014·2013-12-11

    Crunch Pak Apple Slices Recalled for Potential Listeria Contamination

    Crunch Pak, LLC is recalling specific packages of Tart Apple Slices due to potential contamination with Listeria monocytogenes. The products were distributed across 28 states.

    Product
    Crunch Pak Tart Apple Slices, 6/2 ounce bags packaged in a clamshell. The UPC on the clamshell is 7 32313 12103 4. Crunch Pak Tart Apple Slices, 14 ounce bag. The UPC is 7 32313 14120 9. Crunch Pak Tart Apple Slices, 3 pound bag. The UPC is 7 32313 48120 6. The 6/2…
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Drugs)·D-147-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 5000iu Kits

    Main Street Family Pharmacy, LLC is recalling HCG 5000iu kits due to adverse reactions reported with a different compounded product.

    Product
    HCG 5000iu kit, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0624-2014·2013-12-11

    Garden-Fresh Recalls Tomato Mozzarella Salad Kits Due to Listeria Risk

    Garden-Fresh Foods is recalling Tomato Mozzarella Salad Kits because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Tomato Mozzarella Salad Kit, Product Code 0 11596 55163 0, 1/5 lb
    Category
    Food
    Distribution
    10 states