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.

18551–18575 of 32108

  • SevereFDA (Drugs)·D-0194-2017·2016-12-21

    Cantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 2,509 single-dose Hydromorphone HCl syringes nationwide due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0202-2017·2016-12-21

    Cantrell Drug Recalls Rocuronium Bromide Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 5,067 syringes of Rocuronium Bromide 50 mg/5 mL injection solution nationwide due to a lack of assurance of sterility.

    Product
    Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2017·2016-12-21

    Cantrell Drug Recalls Fentanyl Citrate Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0697-2017·2016-12-21

    First Source Recalls Sunflower Kernels for Listeria Contamination Risk

    First Source LLC is recalling specific lots of roasted and unsalted sunflower kernels due to potential Listeria monocytogenes contamination.

    Product
    ROASTED & UNSALTED SUNFLOWER KERNELS sold under the following labels: 1) ROASTED & UNSALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 2) Tops square tub ROASTED & UNSALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 3) EARTH FARE ROASTED & UNSALTED…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0706-2017·2016-12-21

    Troyer Cheese Recalls Backroad Country Honey Island Crunch Mix for Listeria Risk

    Troyer Cheese Inc is recalling Backroad Country Honey Island Crunch Mix due to potential Listeria monocytogenes contamination. The product was distributed to 26 states.

    Product
    BACKROAD COUNTRY HONEY ISLAND CRUNCH MIX ,Net Wt. 9 oz (256g) Product Code 15356 BEST IF USED BY 05/2017
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-0702-2017·2016-12-21

    First Source Recalls Flave! Beach Retreat Trail Mix for Listeria Risk

    First Source LLC is recalling Flave! Beach Retreat Trail Mix due to potential Listeria monocytogenes contamination. The product was distributed in 11 states.

    Product
    Flave! BEACH RETREAT TRAIL MIX, Net Wt. 18.5 OZ (1 LB 2.5 OZ) 524g, packed 12 per case
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0191-2017·2016-12-21

    Cantrell Drug Recalls Glycopyrrolate Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Glycopyrrolate injection because the firm cannot assure the sterility of the product.

    Product
    Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0709-2017·2016-12-21

    Troyer Cheese Recalls Sunflower Seeds for Listeria Risk

    Troyer Cheese Inc is recalling 30 lb bags of Backroad Country Roasted and Salted Sunflower Seeds due to potential Listeria monocytogenes contamination.

    Product
    BACKROAD COUNTRY ROASTED AND SALTED SUNFLOWER SEEDS ,Net Wt. 30 lb bag, UPC 1 13671 02091 5 Product Code 15318 BEST IF USED BY 05/2017
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Drugs)·D-0192-2017·2016-12-21

    Cantrell Drug Recalls Heparin Sodium Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 1,494 syringes of Heparin Sodium due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2017·2016-12-21

    Cantrell Drug Recalls Heparin Sodium Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 150 bags of Heparin Sodium 5,000 USP Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0698-2017·2016-12-21

    First Source Recalls Cranberry Delight Products for Listeria Risk

    First Source LLC is recalling various Sunshine Cranberry Delight products due to potential contamination with Listeria monocytogenes.

    Product
    SUNSHINE CRANBERRY DELIGHT sold under the following labels: 1) Wegmans square tub SUNSHINE CRANBERRY DELIGHT, 20 oz, shipped 12 packs per case, 2) 15 LBS ALPINE VALLEY SUNSHINE CRANBERRY DELIGHT, shipped 1 per case, 3) SUNSHINE CRANBERRY DELITE, NET WT 4.5 OZ (127g) shipped 6…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0318-2017·2016-12-21

    Big Y Cranberry Nut Trail Mix Recalled for Listeria Contamination

    Big Y cranberry nut trail mix is being recalled because it may be contaminated with Listeria monocytogenes. The product was distributed to 43 states.

    Product
    Big Y cranberry nut trail mix in plastic tub NET WT 20 OZ (1 LB 4 OZ) 567g INGREDIENTS: CRANBERRIES***PEANUTS, PEANUT OIL, RAISINS, SUNFLOWER KERNELS, PEPITAS, WALNUTS. CONTAINS: PEANUTS, WALNUTS UPC 0 18894 00457 8 DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, ma 01104
    Category
    Food
    Distribution
    43 states
  • SevereNHTSA·16V922000·2016-12-21

    GM Recalls 2016 Buick Envision for Brake Line Cracking Risk

    General Motors is recalling 2016 Buick Envision vehicles because master cylinder brake lines may crack and leak fluid, potentially reducing braking performance.

    Product
    BUICK — BUICK ENVISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0316-2017·2016-12-21

    Hickory Harvest Trail Mix Recalled for Listeria Contamination Risk

    Ohio Hickory Harvest Brand Products Inc. is recalling Sweet & Salty Trail Mix because it may be contaminated with Listeria monocytogenes.

    Product
    Hickory Harvest FOODS Sweet & Salty Trail Mix 25 lb. UPC 0-36232-00510-0, 4.5oz UPC 0-36232-06075-5. INGREDIENTS: Peanuts, Raisins***Sunflower Kernel*** AKRON, OH 44319 UPC 0 36232 00510 0
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Food)·F-0696-2017·2016-12-21

    First Source Recalls Sunflower Kernels for Listeria Contamination Risk

    First Source LLC is recalling specific lots of roasted and salted sunflower kernels due to potential Listeria monocytogenes contamination.

    Product
    ROASTED & SALTED SUNFLOWER KERNELS sold under the following labels: 1) ROASTED & SALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 2) Tops square tub ROASTED & SALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 3) EARTH FARE ROASTED & SALTED SUNFLOWER…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0190-2017·2016-12-21

    Cantrell Drug Company Recalls Fentanyl and Bupivacaine Bags for Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Fentanyl Citrate and Bupivacaine HCl bags due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0711-2017·2016-12-21

    Apple Tree Goat Dairy French Herb Chevre Recalled for Listeria Risk

    Apple Tree Goat Dairy is recalling French Herb Chevre due to potential Listeria monocytogenes contamination. The product was distributed in DC, MD, NJ, NY, PA, and VA.

    Product
    Apple Tree Goat Dairy French Herb Chevre, Net WT. 8 oz shrink wrap and 5 lb. block; Richfield, PA 17086.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0314-2017·2016-12-21

    Roasted Sunflower Kernels Recalled for Potential Listeria Contamination

    Ohio Hickory Harvest Brand Products Inc. is recalling roasted and salted sunflower kernels under multiple brands due to potential Listeria monocytogenes contamination.

    Product
    Roasted & Salted Sunflower Kernels under the following brand names: AMISH FARMS SALEM, OHIO 44460 5.5 oz plastic bag UPC 8 55993 20018 6, heinen's Warrensville Heights, OH 44128 NET WT 10 oz tub UPC 0 36232 07703 9, Hickory Harvest FOODS Akron, OH 44319 5 oz plastic tube UPC 0…
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Drugs)·D-0198-2017·2016-12-21

    Cantrell Drug Recalls Midazolam HCl Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 37 syringes of Midazolam HCl 50 mg/50 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0691-2017·2016-12-21

    Back to Nature Mini Chocolate Chunk Cookies Recalled for Undeclared Milk

    Back to Nature Foods is recalling specific lots of Mini Chocolate Chunk Cookies because they contain undeclared milk, a major food allergen.

    Product
    Back to Nature Mini Chocolate Chunk Cookies, 6 - 1.25oz (35g) UPC 8-19898-01114-8 (tray) and UPC 8-19898-01115-5 (pouch); 100 - 1.25oz (35g) UPC 8-19898-01148-3 (case) and UPC 8-19898-01115-5 (pouch), 50 - 2.5oz (70g) UPC 8-19898-01139-1 (case) and UPC 8-19898-01143-8 (pouch)…
    Category
    Food
    Distribution
    38 states
  • SevereFDA (Food)·F-0742-2017·2016-12-21

    Cargill Recalls Liquid Butter Alternative for Excessive Additives

    Cargill is recalling Beyond Premium Liquid Butter Alternative due to excessive amounts of TBHQ and dimethyl polysiloxane.

    Product
    Beyond PREMIUM LIQUID BUTTER ALTERNATIVE ,ARTIFICIALLY FLAVORED SODIUM FREE, NET/NETO 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL ***TBHQ***DIMETHYLPOLYSILOXANE ***CONTAINS: SOY. UPC 7 58108 08439 1
    Category
    Food
    Distribution
    29 states
  • SevereFDA (Food)·F-0703-2017·2016-12-21

    First Source Recalls Hikers Haven Trail Mix for Listeria Risk

    First Source LLC is recalling Hikers Haven Trail Mix due to potential Listeria monocytogenes contamination. The product was distributed in 11 states.

    Product
    Flave! HIKERS HAVEN TRAIL MIX, Net Wt. 21.5 OZ (1 LB 5.5 OZ) 609g, packed 12 per case
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0187-2017·2016-12-21

    Cantrell Drug Recalls Calcium Chloride Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling 645 vials of Calcium Chloride Injection Solution because the firm cannot assure the sterility of the product.

    Product
    Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0199-2017·2016-12-21

    Cantrell Drug Recalls Morphine Sulfate Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 1,748 bags of Morphine Sulfate 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75
    Category
    Drug
    Distribution
    Distributed nationwide