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.

20676–20700 of 32121

  • SevereFDA (Drugs)·D-0707-2016·2016-02-24

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

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

    Product
    papaverine phentolamine prostaglandin; 30/2 mg/20 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
  • SevereFDA (Drugs)·D-0682-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Hydroxyprogesterone Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of hydroxyprogesterone in sesame oil because FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0681-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Hydroxycobalamine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded Hydroxycobalamine 30 mg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0608-2016·2016-02-24

    Umpqua Dairy Recalls Vanilla Soft Serve Mix Due to Antibiotic Concerns

    Umpqua Dairy Products Co is recalling Dairy Queen Vanilla Soft Serve Mix because the milk used was presumptive positive for beta-lactam antibiotics.

    Product
    Dairy Queen Vanilla Soft Serve Mix, item no. 04960, 5 gallon container. UPC 0 71203 00489 8
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0666-2016·2016-02-24

    Alcon Recalls TEARS Naturale FREE Eye Drops Due to Sterility Concerns

    Alcon is recalling TEARS Naturale FREE eye drops because some vials may contain water instead of the product, creating a sterility risk.

    Product
    TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0711-2016·2016-02-24

    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 assurance of sterility.

    Product
    papaverine phentolamine prostaglandin; 35/1.5 mg/50 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-0684-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Insulin 70/30 Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Insulin 70/30 after FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0683-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Hydroxyprogesterone Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded hydroxyprogesterone products in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    hydroxyprogesterone w/ pres; 1 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-0698-2016·2016-02-24

    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; 22.5/0.83 mg/8.3 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
  • SevereFDA (Food)·F-0618-2016·2016-02-24

    Red Diamond Coffee Concentrate Recalled for Elevated pH Levels

    Red Diamond, Inc. is recalling 302 units of Colombian Coffee Concentrate due to elevated pH levels in an acidified product. The product was distributed in six states.

    Product
    RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111589
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0820-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects

    Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire during surgery.

    Product
    Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0713-2016·2016-02-24

    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
    papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0528-2016·2016-02-24

    AA USA Trading Recalls Dried Fruit Slices for Undeclared Dyes and Sulfites

    AA USA Trading Inc. is recalling Dried Kiwi Slices and Dried Tai Sweet Mango Slices because they contain undeclared food dyes and sulfites.

    Product
    Dried Kiwi Slice, Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882 UPC 6 944155 210041
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0677-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Calcium Compounds for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded calcium products in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0600-2016·2016-02-24

    Uncle Buck's Fish Batter Mix Recalled for Undeclared Milk Ingredient

    BlendTech Inc is recalling Uncle Buck's Fish Batter Mix Original because it contains an undeclared milk ingredient. The product was distributed nationwide.

    Product
    Uncle Buck's Fish Batter Mix Original, packaged in 22 oz. (623 g) plastic bottles, bottle lot #09241505, UPC 09229725284 and packed 12 bottles/case. Bottles were shipped in cases under lot #09241506 and lot #09241507. Produced and Packaged in the USA for Bass Pro Shops By…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0693-2016·2016-02-24

    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 lack of sterility assurance found during an FDA inspection.

    Product
    papaverine phentolamine prostaglandin; 12/1 mg/10 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
  • SevereFDA (Drugs)·D-0686-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of methylcobalamine 1 mg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0688-2016·2016-02-24

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

    Abbott's Compounding Pharmacy is recalling all unexpired lots of papaverine prostaglandin 30 mg/30 mcg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0805-2016·2016-02-24

    Varian Eclipse Treatment Planning System Recall for Dose Calculation Error

    Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.

    Product
    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0695-2016·2016-02-24

    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
    papaverine phentolamine prostaglandin; 12/1 mg/30 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-0690-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Papaverine Phentolamine Products

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded papaverine phentolamine products due to concerns about lack of sterility assurance found during an FDA inspection.

    Product
    papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0703-2016·2016-02-24

    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; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0821-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles

    Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.

    Product
    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0679-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 5 mg/mL, 30 mL, after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state