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.

18251–18275 of 29217

  • SevereFDA (Drugs)·D-1339-2016·2016-07-20

    Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,200 units of Rocuronium 10mg/ml syringes because the company cannot ensure the product is sterile.

    Product
    Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1344-2016·2016-07-20

    Pharmakon Recalls Sufentanil and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.

    Product
    Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL because the company cannot ensure the products are sterile.

    Product
    Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2016·2016-07-20

    Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V543000·2016-07-19

    Blue Bird Vision Transit Buses Recalled for Propane Fuel Line Defect

    Blue Bird is recalling 2016-2017 Vision transit buses with 6.8L Ford engines and Gen 3 propane units because fuel lines may rub, causing leaks and fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V541000·2016-07-19

    Ditch Witch T14MV Trailer Recalled for Brake Wiring Defect

    Charles Machine Works is recalling 2016 Ditch Witch T14MV trailers because an incorrect wiring harness may prevent brakes from applying if the trailer separates from the tow vehicle.

    Product
    DITCH WITCH — DITCH WITCH T14MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V540000·2016-07-19

    BMW Recalls 2015 M5 and M6 Models for Driveshaft Weld Defect

    BMW is recalling 956 model year 2015 M5 and M6 vehicles because a defective driveshaft weld may cause loss of propulsion or vehicle rolling, increasing crash risk.

    Product
    BMW — BMW M5, M6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V537000·2016-07-19

    Spartan Motors Recalls Transit Bus Chassis Cabs Due to Frame Cracks

    Spartan Motors is recalling 2011-2015 Transit Bus Chassis Cabs because frames may crack, potentially reducing driver control and increasing crash risk.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2016 EXP·2016-07-15

    ConAgra Recalls Frozen Chicken and Beef Entrées Due to Metal Contamination

    ConAgra Foods is recalling approximately 195,597 pounds of frozen P.F. Chang's Home Menu chicken and beef products due to potential metal contamination. No injuries have been reported.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·16223·2016-07-14

    Flushmate III Pressure-Assist Flushing Systems Recalled for Bursting Hazard

    Flushmate is recalling about 453,000 Flushmate III Pressure-Assist Flushing Systems in the U.S. because the units can burst, posing impact and laceration hazards.

    Product
    Flushmate® III Pressure-Assist Flushing Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Midazolam HCl Injection Syringes

    Cantrell Drug Company is recalling 3,853 syringes of Midazolam HCl injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling 884 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1660-2016·2016-07-13

    Pictsweet Frozen Seasoning Blend Recalled for Listeria Risk

    The Pictsweet Company is recalling specific lots of frozen seasoning blends due to potential Listeria monocytogenes contamination in the onion ingredients.

    Product
    Frozen seasoning blend labeled as: a) PICTSWEET(R) Seasoning Blend, recipe helper, NET WT 10 OZ (283g), UPC 70560 96902, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006 b) PICTSWEET(R) Seasoning Blend, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 70560 96911, DISTRIBUTED BY…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1103-2016·2016-07-13

    Reliable Drug Recalls Compounded Lidocaine, Meloxicam, Diclofenac, and Baclofen

    Reliable Drug is recalling compounded lidocaine, meloxicam, diclofenac, and baclofen products due to a lack of processing controls.

    Product
    All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1156-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling fentanyl citrate injection syringes because they contain less active drug than labeled.

    Product
    fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1663-2016·2016-07-13

    Pictsweet Steam'ables Summer Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Steam'ables Seasoned Summer Vegetables because they contain onions that may be contaminated with Listeria monocytogenes.

    Product
    PICTSWEET(R) Steam'ables, Seasoned Summer Vegetables, with Cracked Pepper Seasoning, NET WT 10 OZ (283g), UPC 70560 98001, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1616-2016·2016-07-13

    Norpac Recalls Organic Green Peas for Listeria Contamination Risk

    Norpac Foods is recalling Natural Directions Organic Green Peas due to potential Listeria monocytogenes contamination. The product was distributed in nine states and Guam.

    Product
    Natural Directions Organic Green Peas, frozen, net wt. 12 oz. UPC 0 15400 19670 3
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2122-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports

    Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1068-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Biotin Capsules Due to Labeling Error

    Reliable Compounding Pharmacy is recalling Biotin 100 mg capsules because they were found to contain 4-aminopyridine instead of the labeled ingredient.

    Product
    CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereUSDA FSIS·059-2016·2016-07-13

    Michael Angelo's Recalls Frozen Shrimp Scampi for Undeclared Allergens

    Michael Angelo's Gourmet Foods is recalling frozen shrimp scampi products that may contain undeclared chicken, egg, and soy due to a packaging error.

    Product
    Michael Angelo's Gourmet Foods Inc. — Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2016·2016-07-13

    Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns

    Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.

    Product
    TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1653-2016·2016-07-13

    Pictsweet Recalls Frozen Pepper and Onion Blends for Listeria Risk

    The Pictsweet Company is recalling frozen three pepper and onion blends sold under Harris Teeter, Kroger, and Pictsweet brands due to potential Listeria monocytogenes contamination.

    Product
    Frozen three pepper and onion blends labeled as: a) Harris Teeter(TM) brand THREE PEPPER & ONION BLEND, NET WT 12 OZ (340g), UPC 72036 71681, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105 b) Kroger(R) 3 PEPPER & ONION BLEND, onions, green bell peppers…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1662-2016·2016-07-13

    Pictsweet Gumbo Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Pictsweet Gumbo Vegetables because the onions used in the product were recalled for possible Listeria monocytogenes contamination.

    Product
    PICTSWEET(R) Gumbo Vegetables, NET WT 12 OZ (340g), UPC 70560 95995, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide