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.

20701–20725 of 32121

  • SevereFDA (Drugs)·D-0694-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products because FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V106000·2016-02-24

    Temsa Recalls 2016 TS45 and TS35C Buses for Front Control Arm Defect

    Temsa is recalling 70 model year 2016 TS45 and TS35C buses because front lower control arm housings may crack. This defect could cause a loss of steering and increase the risk of a crash.

    Product
    TEMSA — TEMSA TS45, TS35C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0700-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0712-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0663-2016·2016-02-24

    Medline Acetaminophen Tablets Recalled for Incorrect Strength Labeling

    Medline Industries is recalling 325 mg acetaminophen tablets that are actually 500 mg due to a labeling error.

    Product
    ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0709-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0678-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0710-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after an FDA inspection identified concerns regarding the lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0717-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded testosterone cypionate after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0718-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Papaverine Phent Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of papaverine phent sterile compounded products because an FDA inspection found concerns regarding the assurance of sterility.

    Product
    papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0704-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection identified concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0696-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0676-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Bupivacaine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of Bupivacaine 0.25% sterile compounded products because an FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0527-2016·2016-02-24

    Dried Mango and Kiwi Slices Recalled for Undeclared Food Dyes and Sulfites

    AA USA Trading Inc. is recalling dried mango and kiwi slices due to undeclared food dyes and sulfites. The products were distributed in New Jersey and New York.

    Product
    Dried Tai Sweet Mango Slice, Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882 UPC 6 944155 210102
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0599-2016·2016-02-24

    Wegmans Butternut Squash Ravioli Recalled for Undeclared Tree Nuts

    Wegmans is recalling Italian Classics Butternut Squash Ravioli because it contains undeclared cashews and almonds.

    Product
    Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI, NET WT 9 OZ, UPC #77890 36434, KEEP REFRIGERATED, PRODUCT OF ITALY
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0616-2016·2016-02-24

    Giant Eagle Recalls Soft Pretzels for Undeclared Walnuts

    Giant Eagle is recalling approximately 23,000 units of soft pretzels sold in Pennsylvania, Ohio, and Indiana because they contain undeclared walnuts.

    Product
    Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as: New Year's Pretzel Sell By: 01/04/2016 PLU: 39739 UPC: 23979 80499
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0597-2016·2016-02-24

    Cape Cod Cranberry Candy Recalled for Undeclared Almonds

    Cape Cod Provisions LLC is recalling specific lots of chocolate and yogurt-covered cranberries because they may contain undeclared almonds.

    Product
    Dark Chocolate, Milk Chocolate, & Yogurt Covered cranberries, Net Wt. 5 oz (140g) Packaged under the following names: Cape Cod Cranberry Candy" UPC 6 12681 10259 3 and Harvest Sweets" UPC 6 12681 44259 0.
    Category
    Food
    Distribution
    20 states
  • SevereNHTSA·16V102000·2016-02-23

    Kawasaki Recalls 2016 Ninja ZX-10R Motorcycles for Steering Bolt Defect

    Kawasaki is recalling 544 model year 2016 Ninja ZX-10R motorcycles because steering damper bracket mounting bolts may break, potentially interfering with steering and increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA ZX-10R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V100000·2016-02-23

    Blue Bird Recalls 2008-2009 Vision School Buses for Fire Risk

    Blue Bird is recalling 733 model year 2008-2009 Vision school buses because a wiring defect may cause the battery cable to overheat, melt, and create a fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V101000·2016-02-23

    Blue Bird Recalls 2009 Vision Transit Buses for Electrical Fire Risk

    Blue Bird is recalling 2009 Vision transit buses with Caterpillar C707 engines because a wiring defect may cause the battery cable to overheat, melt, and create a fire hazard.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V099000·2016-02-19

    Mack Trucks Recalls 2012-2016 Models for Driveshaft Cap Nut Defect

    Mack Trucks is recalling 33,981 model year 2012-2016 trucks because a cap nut may loosen, causing the driveshaft to disconnect and increasing crash risk.

    Product
    MACK — MACK TITAN (TD), PINNACLE (CHU), TERRAPRO (LEU), PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V096000·2016-02-19

    Toyota Recalls RAV4 Models Due to Rear Seat Belt Cut Risk

    Toyota is recalling 2006-2012 RAV4 and 2012-2014 RAV4 EV vehicles because rear seat belts may be cut by the seat cushion frame in a frontal collision, increasing injury risk.

    Product
    TOYOTA — TOYOTA RAV4, RAV4 EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V098000·2016-02-19

    Mack Trucks Recalls 2016-2017 Granite and TerraPro for Steering Defect

    Mack Trucks is recalling 1,187 model year 2016-2017 Granite and TerraPro trucks because a missing roll pin may cause the steering shaft to disconnect, resulting in a complete loss of steering.

    Product
    MACK — MACK TERRAPRO (MRU), GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V095000·2016-02-19

    Volvo Trucks Recall 2009-2016 Models for Steering Component Failure Risk

    Volvo Trucks North America is recalling certain 2009-2010 VT and 2016 VNL/VNM trucks because front suspension drag links may corrode, potentially causing loss of steering.

    Product
    VOLVO — VOLVO VT, VNM, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide