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.

27026–27050 of 32219

  • SevereFDA (Drugs)·D-318-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Tri-Mix SS Pap Injection Vials

    Main Street Family Pharmacy is recalling 7 units of Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml vials due to reports of skin abscesses.

    Product
    Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-213-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

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

    Product
    Methylprednisolone 40 w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-161-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lidocaine 1% Vials

    Main Street Family Pharmacy is recalling Lidocaine 1% 30ml vials due to adverse reactions reported for a different compounded product.

    Product
    Lidocaine 1% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0452-2014·2013-12-11

    Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend

    Synthes USA is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System because two lots are missing a required second bend in the nail.

    Product
    Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-309-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Tetracaine 2% Due to Adverse Reactions

    Main Street Compounding Pharmacy is recalling Tetracaine 2% after receiving reports of skin abscesses linked to a different compounded product.

    Product
    Tetracaine 2%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0656-2014·2013-12-11

    Garden-Fresh Foods Recalls Taco Dip Products for Listeria Contamination Risk

    Garden-Fresh Foods is recalling specific varieties of ready-to-eat taco dip because they may be contaminated with Listeria monocytogenes.

    Product
    Grandpas Taco Dip, Product Code 0 11596 55903 2 1/5 lb; Finest Traditions Taco Dip, Product Code 10 733147 10557 0, 6/8 oz; Roundy's Taco Dip, Product Code 0 11150 52604 3,2013 6/12 oz; Maggie's Taco Dip, Product Code 0 11596 06201 3, 6/12 oz
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-043-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls B-12 Methyl Vials

    Main Street Family Pharmacy is recalling 7 units of B-12 (Methyl) 30ml vials due to reports of skin abscesses linked to a different compounded product.

    Product
    B-12 (Methyl) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-224-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials

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

    Product
    Methylprednisolone 80mg w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-258-2014·2013-12-11

    Main Street Family Pharmacy Recalls Compounded Methylprednisolone Vials

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

    Product
    Post-menopausal HCG Pk 3rd mont, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-120-2014·2013-12-11

    Main Street Family Pharmacy Recalls HCG 220 iu Prefilled Syringes

    Main Street Family Pharmacy is recalling HCG 220 iu prefilled syringes due to reports of adverse reactions involving skin abscesses.

    Product
    HCG 220 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-185-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotropic 2ml PFS Units

    Main Street Family Pharmacy, LLC is recalling 6 units of Lipotropic 2ml PFS due to reports of skin abscesses linked to a related compounded product.

    Product
    Lipotropic 2ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2014·2013-12-11

    American Health Packaging Recalls Subpotent Valacyclovir HCl Tablets

    American Health Packaging is recalling 1,536 cartons of Valacyclovir HCl 500 mg tablets because they contain less active ingredient than labeled.

    Product
    Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-275-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Taper A Prefilled Syringes

    Main Street Family Pharmacy is recalling Taper A prefilled syringes due to reports of skin abscesses linked to compounded methylprednisolone.

    Product
    Taper A prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-084-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls EDTA 3% 30ml Vials

    Main Street Family Pharmacy is recalling EDTA 3% 30ml vials due to reports of adverse reactions linked to a different compounded product.

    Product
    EDTA 3% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-255-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Pontocaine 2% Due to Adverse Reactions

    Main Street Family Pharmacy, LLC is recalling 10 units of Pontocaine 2% 4 oz following seven reports of skin abscesses.

    Product
    Pontocaine 2% 4 oz, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-177-2014·2013-12-11

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

    Main Street Compounding Pharmacy is recalling 5 units of Lipotonix Plus 30ml w/o methion after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Lipotonix Plus 30ml w/o methion, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-216-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscesses

    Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Methylprednisolone 40mg PF 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-208-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports

    Main Street Family Pharmacy is recalling 24 units of Methylcobalamin 1mg/ml 30ml vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Methylcobalamin 1mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-227-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

    Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Mic 25/50/50 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-108-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 12000u Due to Adverse Reactions

    Main Street Family Pharmacy is recalling HCG 12000u vials after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    HCG 12000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-102-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Gomenol Due to Skin Abscess Reports

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

    Product
    Gomenol 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0630-2014·2013-12-11

    Garden-Fresh Recalls Broccoli Cheese Salad Base Due to Listeria Risk

    Garden-Fresh Foods is recalling Broccoli Cheese Salad Base products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Broccoli Cheese Salad Base,Product Code 0 11596 55136 4, 1/5.25lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-061-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone 9mg/ml PF Vials

    Main Street Compounding Pharmacy is recalling Betamethasone 9mg/ml PF vials due to reports of skin abscesses linked to a related compounded product.

    Product
    Betamethasone 9mg/ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-116-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 200 iu Prefilled Syringes

    Main Street Family Pharmacy, LLC is recalling HCG 200 iu prefilled syringes due to adverse reactions reported for a different compounded product.

    Product
    HCG 200 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide