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.

18026–18050 of 29217

  • SevereFDA (Drugs)·D-1361-2016·2016-07-27

    PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution due to the presence of glass particulate matter.

    Product
    0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1363-2016·2016-07-27

    PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 15 bags of compounded morphine and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1763-2016·2016-07-27

    Organic Vegetable Medley Recalled for Potential Listeria Contamination

    CRF Frozen Foods is recalling Organic Premium Blend Vegetable Medley with Shelled Edamame due to potential Listeria monocytogenes contamination.

    Product
    Frozen Organic Premium Blend Vegetable Medley with Shelled Edamame, Organic by Nature brand, net wt. 5 lb. The UPC is 8 46358 00065 7. Product label bears cooking instructions and listed as: MICROWAVE 1. Pour one quarter contents of bag into a microwave safe dish with…
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1404-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates

    PharMEDium Services, LLC is recalling 85 cassettes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1384-2016·2016-07-27

    PharMEDium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

    PharMEDium Services, LLC is recalling 1,577 syringes of compounded hydrocodone and bupivacaine injectable drugs nationwide due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1693-2016·2016-07-27

    Clif Bar Nuts & Seeds Energy Bar Recalled for Listeria Risk

    Clif Bar is recalling Nuts & Seeds energy bars because a supplier notified the firm that sunflower kernels may be contaminated with Listeria monocytogenes.

    Product
    CLIF BAR Nuts & Seeds energy bar, 68 g bar. Almonds, Peanuts, Pumpkin Seeds UPC: 7-22252-16101-7; 12 count and 6 count packages INGREDIENTS: Organic Brown Rice Syrup, Organic Rolled Oats, Soy Protein Isolate, Sunflower Seeds, Organic Almonds, Organic Cane Syrup, Organic…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1391-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 17,990 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.

    Product
    2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1717-2016·2016-07-27

    Atkins Nutritionals Recalls Caramel Double Chocolate Crunch Bars Due to Listeria Risk

    Atkins Nutritionals is recalling Caramel Double Chocolate Crunch Bars because they may be contaminated with Listeria monocytogenes from sunflower seeds.

    Product
    Caramel Double Chocolate Crunch Bar 6x5, UPC: 637480035057, Case UPC: 637480039055. Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services, LLC is recalling 555 sterile injectable drug cassettes containing Hydromorphone HCl and Bupivacaine HCl due to the presence of glass particulate matter.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1394-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services is recalling 1,280 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1385-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services is recalling 30 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1696-2016·2016-07-27

    Clif Bar Sierra Trail Mix Recalled for Listeria Risk

    Clif Bar and Company is recalling Sierra Trail Mix bars due to potential Listeria monocytogenes contamination in sunflower kernels.

    Product
    CLIF BAR Sierra Trail Mix/ Melange Montagnard Sierra; 68 g bar; 12 ct packages UPC: 7-22252-12115-8 Canadian distribution only. INGREDIENTS: BROWN RICE SYRUP*, SOY RICE CRISPS (SOY PROTEIN ISOLATE, RICE FLOUR, BARLEY MALT EXTRACT), ROLLED OATS*, RAISINS*, PEANUTS*…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1365-2016·2016-07-27

    Pharmedium Recalls Bupivacaine HCl Bags Due to Glass Particulate Matter

    Pharmedium Services, LLC is recalling 8,581 bags of 0.125% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

    Product
    0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V561000·2016-07-27

    Jayco Recalls 2016-2017 Precept and Alante Motorhomes for Seat Defect

    Jayco is recalling 2016-2017 Precept and Alante motorhomes because the driver's seat may loosen and detach from the base, increasing the risk of a crash.

    Product
    JAYCO — JAYCO PRECEPT, ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1740-2016·2016-07-27

    Rucker's Recalls Cajun Hot Mix Due to Listeria Contamination

    Rucker's Wholesale & Service Co. is recalling 3,915 bags of Cajun Hot Mix because sunflower kernels are contaminated with Listeria monocytogenes.

    Product
    Cajun Hot Mix 6 OZ. packaged in clear plastic bags with sticker label. This product has multiple brands. All brands are under the same UPC 052545002681. Brand names include Big R. Stores, Bomgaar's, C-A-L Ranch Store's, Coastal, Family Choice, Fin Feather Furn Outfitter's…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1744-2016·2016-07-27

    Rucker's Recalls Cajun Hot Mix Due to Listeria Contamination

    Rucker's Wholesale & Service Co. is recalling 24,112 bags of Cajun Hot Mix because sunflower kernels are contaminated with Listeria monocytogenes.

    Product
    CAJUN HOT MIX 8 OZ. packaged in a clear plastic bag with sticky label under the UPC number 052545022689, and several brand names, including ATWOOD'S RANCH & HOME, BASS PRO SHOP'S UNCLE BUCK'S, BIG R STORE'S, CABELA'S CLASSIC'S, CABELA'S OUTFITTER CLASSIC, FARM & HOME SUPPLY, F &…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1368-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulates

    PharMEDium Services, LLC is recalling 2,874 bags of 0.25% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 10 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1399-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services, LLC is recalling 21 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1434-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services is recalling 650 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1409-2016·2016-07-27

    Pharmedium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

    Pharmedium Services is recalling 435 syringes of compounded hydrocodone and bupivacaine due to glass particulate contamination.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1376-2016·2016-07-27

    PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services, LLC is recalling 25 bags of compounded Sufentanil and Bupivacaine injectable solution because the active ingredient was contaminated with glass particulate.

    Product
    1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V558000·2016-07-26

    Forest River Recalls 2011-2016 Glaval Titan II Buses for Frame Cracks

    Forest River is recalling 39 Glaval Titan II Low Floor buses due to frames that may crack, potentially reducing driver control and increasing crash risk.

    Product
    GLAVAL BUS — GLAVAL BUS TITAN II LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V559000·2016-07-26

    2015 RAM 2500 and 3500 Recalled for Steering Bracket Weld Defect

    Chrysler is recalling 2015 RAM 2500 and 3500 trucks because inadequate welds on front track bar brackets may separate, reducing steering response and increasing crash risk.

    Product
    RAM — RAM 2500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide