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.

27126–27150 of 32219

  • SevereFDA (Drugs)·D-181-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotropic 1.5ml PFS Units

    Main Street Family Pharmacy is recalling 10 units of Lipotropic 1.5ml PFS due to adverse reactions reported for a related compounded product.

    Product
    Lipotropic 1.5ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-164-2014·2013-12-11

    Main Street Family Pharmacy Recalls Compounded Lidocaine and Phenylephrine

    Main Street Family Pharmacy is recalling Lidocaine 4%/Phenylephrine 1% 5 due to adverse reaction reports linked to a related compounded product.

    Product
    Lidocaine 4%/Phenylephrine 1% 5, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-276-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Taper Pack B Due to Skin Abscesses

    Main Street Compounding Pharmacy is recalling Taper Pack B after receiving seven reports of skin abscesses potentially linked to the product.

    Product
    Taper Pack B, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-187-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotropic 50ml Vials

    Main Street Family Pharmacy is recalling Lipotropic 50ml vials due to seven reports of skin abscesses linked to a related compounded product.

    Product
    Lipotropic 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-062-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone Vials Due to Skin Abscesses

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

    Product
    Betamethasone 10mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-288-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Testosterone Cypionate Vials

    Main Street Compounding Pharmacy is recalling Testosterone Cypionate vials due to adverse reactions reported with a different compounded product.

    Product
    Testosterone Cypionate, 200mg 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-319-2014·2013-12-11

    Main Street Family Pharmacy Recalls Compounded Methylprednisolone Vials

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

    Product
    Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0602-2014·2013-12-11

    Garden-Fresh Foods Recalls Tuna Pasta Salad for Listeria Risk

    Garden-Fresh Foods is recalling Finest Traditions Tuna Pasta Salad and other ready-to-eat products due to potential Listeria monocytogenes contamination.

    Product
    Finest Traditions Tuna Pasta Salad, Product Code 10 733147 10067 4, 1/8 lb
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-193-2014·2013-12-11

    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 300ml pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-023-2014·2013-12-11

    Hospira Recalls Morphine Sulfate Injection Due to Vial Leakage

    Hospira is recalling 29,700 vials of Morphine Sulfate Injection because a confirmed report indicated vial neck breakage caused leakage, compromising sterility.

    Product
    Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-183-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Lipotropic 10ml with B-12 and L-Carnitine

    Main Street Compounding Pharmacy is recalling Lipotropic 10ml with B-12 and L-Carnitine due to reports of skin abscesses linked to a related compounded product.

    Product
    Lipotropic 10ml with B-12 and L- Carnitine, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-118-2014·2013-12-11

    Main Street Family Pharmacy Recalls Compounded Methylprednisolone Vials

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

    Product
    HCG 2000iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-053-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Betamethasone Vials Due to Skin Abscesses

    Main Street Family Pharmacy is recalling 9 units of Betamethasone 6.5mg 10ml vials after seven reports of skin abscesses potentially linked to the product.

    Product
    Betamethasone 6.5mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-148-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls HCG and Methylprednisolone Products

    Main Street Family Pharmacy, LLC is recalling HCG and methylprednisolone products due to reports of skin abscesses.

    Product
    HCG 500u/ml w/methylc. 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E069000·2013-12-06

    Omix Ada Recalls Jeep Replacement Brake Hoses Due to Leak Risk

    Omix Ada is recalling certain front and rear braided stainless steel replacement brake hoses for modified Jeep vehicles because they may leak fluid or rupture.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V610000·2013-12-06

    Chrysler Recalls 2013 Vehicles for Transmission Output Shaft Fracture Risk

    Chrysler is recalling 2013 Chrysler 300, Dodge Charger, and Ram 1500 vehicles because a transmission output shaft may fracture, potentially causing loss of power or the vehicle rolling away.

    Product
    DODGE — DODGE, CHRYSLER, RAM CHARGER, 300, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0345-2014·2013-12-04

    Renew Life ParaZYME Dietary Supplement Recalled for Chloramphenicol Contamination

    Pacific Nutritionals is recalling Renew Life ParaZYME dietary supplements because the ingredients are contaminated with Chloramphenicol.

    Product
    ParaZYME, 90 capsules per bottle, is dietary supplement and sold under Renew Life brand. The UPC Code 6 31257 30990 7. The product is labeled in parts: "***PARAZYME***renew LIFE***The Digestive Care Company***90 Vegetable Capsules***Distributed by: ReNew Life Formulas***Palm…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0374-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc is recalling specific lots of Plum Organics Pumpkin, Dates, Oats & Chia Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Pumpkin, Dates, Oats & Chia Organic Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0362-2014·2013-12-04

    Plum Organics Tots Blueberry Oats & Quinoa Recalled for Contamination

    Plum Inc is recalling specific lots of Plum Organics Tots Blueberry Oats & Quinoa due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Tots Blueberry Oats & Quinoa Morning Mish Mash - 12.79 oz. box. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0367-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc is recalling Pear and Mango Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Pear and Mango Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0360-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination

    Plum Inc. is recalling Green Bean, Pear & Greek Yogurt organic baby food due to a manufacturing defect leading to post-process contamination.

    Product
    Plum Organics Green Bean, Pear & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0347-2014·2013-12-04

    Renew Life DigestMORE Food Supplements Recalled for Chloramphenicol Contamination

    Pacific Nutritionals is recalling Renew Life DigestMORE and DigestMORE Ultra food supplements because they are contaminated with Chloramphenicol.

    Product
    -DigestMORE, 90 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35000 8. -DigestMORE Ultra, 60 capsules per bottle, Food Supplement is sold under Renew Life brand. The UPC Code 6 31257 35001 5. The DigestMORE product is labeled…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0421-2014·2013-12-04

    DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments

    DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.

    Product
    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide