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.

27101–27125 of 32219

  • SevereFDA (Drugs)·D-075-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Dexamethasone Due to Skin Abscess Reports

    Main Street Family Pharmacy is recalling 17 units of Dexamethasone 8mg 10ml after receiving seven reports of skin abscesses linked to a similar compounded product.

    Product
    Dexamethasone 8mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-157-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls L-Glutamine Vials

    Main Street Family Pharmacy is recalling L-glutamine 30mg/ml vials due to adverse reactions reported for a different compounded product.

    Product
    L-glutamine 30mg/ml 30ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-226-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

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

    Product
    Mic .05ml syrin, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-219-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Methylprednisolone Vials

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

    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-163-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lidocaine 2% Vials

    Main Street Compounding Pharmacy is recalling Lidocaine 2% 30ml vials due to adverse reactions reported for a different compounded product.

    Product
    Lidocaine 2% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-269-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sodium Hyaluronate Vials

    Main Street Family Pharmacy, LLC is recalling 24 units of Sodium Hyaluronate 6ml vials due to adverse reactions reported for a different compounded product.

    Product
    Sodium Hyaluronate 6ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-237-2014·2013-12-11

    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 Ultra 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-268-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Sodium Hyaluronate Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 712 units of Sodium Hyaluronate 2ml vials after receiving seven reports of skin abscesses.

    Product
    Sodium Hyaluronate. 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-170-2014·2013-12-11

    Main Street Family Pharmacy Recalls Lipo Blast Compounded Injection

    Main Street Family Pharmacy is recalling Lipo Blast compounded injections due to reports of skin abscesses.

    Product
    Lipo Blast 50ml, Methionine 25mg, Inositol 50 mg, Choline 100mg, Methyl B-12.25mg, B6 25mg, B5 12.5 mg, Lidocaine 10mg, B7 5mg, adenosine 12.5mg, B1 12.5mg, B2 2.5mg, B3 12.5mg, Benzyl Alcohol .02ml 50mlMain Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-133-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 310 iu Prefilled Syringes

    Main Street Family Pharmacy is recalling HCG 310 iu prefilled syringes due to reports of skin abscesses linked to a different compounded product.

    Product
    HCG 310 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-139-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 370iu Prefilled Syringes

    Main Street Family Pharmacy is recalling HCG 370iu prefilled syringes due to reports of adverse reactions involving skin abscesses.

    Product
    HCG 370iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-107-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG 11000u w/B-12

    Main Street Family Pharmacy is recalling HCG 11000u w/B-12 vials due to seven reports of skin abscesses linked to a different compounded product.

    Product
    HCG 11000u w/B-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-030-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Alphahydroxyprogesterone Vials

    Main Street Family Pharmacy is recalling 17 units of Alphahydroxyprogesterone 250mg due to adverse reactions reported for a different compounded product.

    Product
    Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-056-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone Due to Skin Abscess Reports

    Main Street Compounding Pharmacy is recalling 2 units of Betamethasone 6mg 10ml PF because of seven reports of skin abscesses linked to a related compounded product.

    Product
    Betamethasone 6mg 10ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-169-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipo B Complex Due to Adverse Reactions

    Main Street Family Pharmacy is recalling 20 units of Lipo B Complex 30ml after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Lipo 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-242-2014·2013-12-11

    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 w/B6/B12/Lido 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-063-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Bi-Mix Papaverine and Phentolamine Vials

    Main Street Family Pharmacy is recalling 3 units of Bi-Mix Papaverine and Phentolamine vials due to adverse reaction reports linked to a related compounded product.

    Product
    Bi-Mix Papaverine 30 mg Phentolamine 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-074-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Dexamethasone Due to Skin Abscess Reports

    Main Street Compounding Pharmacy is recalling Dexamethasone 8/4 10ml and 30 ml vials after seven reports of skin abscesses linked to a related compounded product.

    Product
    Dexamethasone 8/4 10ml and 30 ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-069-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Compounded Cyclosporine Drops

    Main Street Family Pharmacy, LLC is recalling 15 units of compounded Cyclosporine Drops due to adverse reactions reported for a different compounded product.

    Product
    Cyclosporine Drops (compounded), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0648-2014·2013-12-11

    Garden-Fresh Foods Recalls Mint Chocolate Mousse for Listeria Contamination

    Garden-Fresh Foods is recalling Finest Traditions Mint Chocolate Mousse because it may be contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Mint Chocolate Mousse, Product Code 10 733147 11017 8 11/4/2013 - 11/18/2013 1/5 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-029-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Adenosine Monophosphate Vials

    Main Street Family Pharmacy is recalling 15 units of Adenosine Monophosphate due to adverse reaction reports involving a different compounded product.

    Product
    Adenosine Monophosphate, 50mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide