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.

21551–21575 of 32121

  • SevereFDA (Food)·F-0124-2016·2015-11-04

    Sunkist Frozen Mango Sorbet Bars Recalled for Undeclared Milk

    Dean Foods is recalling Sunkist Frozen Mango Fruit Sorbet Bars because they contain undeclared milk, a major allergen.

    Product
    Sunkist Frozen Mango Fruit Sorbet Bar 6 x 2.5 FL OZ. (74 mL) Bars/ 15 FL OZ (444 mL) and pint (473 mL) UPC: 51819-00303
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0151-2016·2015-11-04

    Moses Lake Pharmacy Recalls Trimix Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling Trimix injectable solution because the FDA cannot assure the sterility of the compounded drug.

    Product
    TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0156-2016·2015-11-04

    Park Compounding Pharmacy Recalls Prostaglandin PGE-1 Due to Sterility Concerns

    Park Compounding Pharmacy is recalling specific vials of Prostaglandin PGE-1 because the agency could not ensure the products remained sterile.

    Product
    PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0121-2016·2015-11-04

    American Pure Whey Protein Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Whey Protein Matrix Vanilla flavor due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Matrix Vanilla flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Drugs)·D-0121-2016·2015-11-04

    Moses Lake Professional Pharmacy Recalls Sermorelin Injectable Solution

    Moses Lake Professional Pharmacy is recalling 165 syringes of Sermorelin/GHRP-6/GHRP-2 injectable solution due to a lack of assurance of sterility.

    Product
    SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0125-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 92 testosterone pellets because the company cannot ensure they are sterile. The recall covers products distributed nationwide.

    Product
    TESTOSTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2016·2015-11-04

    FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

    FDA is recalling Testosterone/Anastrozole pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the sterile compounded drugs are sterile.

    Product
    TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2016·2015-11-04

    FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling Testosterone/Anastrozole pellets because the FDA identified a lack of assurance of sterility for the compounded drugs.

    Product
    TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2016·2015-11-04

    Moses Lake Pharmacy Recalls Dihydroergotamine Mesylate Injectable Syringes

    JD & SN Inc. is recalling 8 syringes of Dihydroergotamine Mesylate Injectable Solution due to a lack of assurance of sterility.

    Product
    DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2016·2015-11-04

    Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

    Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

    Product
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0096-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling Hydroxocobalamin syringes because the FDA cannot assure the products are sterile.

    Product
    HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Testosterone Cypionate Injectable Solution

    Moses Lake Professional Pharmacy is recalling compounded Testosterone Cypionate injectable solution due to a lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0118-2016·2015-11-04

    American Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk

    American Pure Whey is recalling Whey Protein Isolate (Chocolate flavor) in 2 lb. and 5 lb. containers due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Isolate (Chocolate flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Drugs)·D-0106-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling Methylcobalamin MDV Injectable Solution due to a lack of assurance of sterility. The recall covers all sterile human compounded drugs within their expiry dates.

    Product
    METHYLCOBALAMIN MDV, Injectable Solution, 2 MG/ML, 10mL syringe; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2016·2015-11-04

    FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    JD & SN Inc. is recalling 25 mg testosterone pellets because the agency cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TESTOSTERONE, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0169-2016·2015-11-04

    Welch Allyn KleenSpec Corded Illuminator Recalled for Electric Shock Risk

    Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.

    Product
    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0122-2016·2015-11-04

    American Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk

    American Pure Whey is recalling Whey Protein Isolate (Vanilla flavor) due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Isolate (Vanilla flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Drugs)·D-0083-2016·2015-11-04

    Moses Lake Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling Estradiol 25 mg pellets because the agency cannot assure the sterility of the compounded drug.

    Product
    ESTRADIOL, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0120-2016·2015-11-04

    Protein Powder Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Build Your Own Body Protein Powder due to undeclared soy and milk allergens.

    Product
    Build Your Own Body, Protein Powder, Manufactured for Build Your Own Body, Flagstaff Arizona.
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Food)·F-0116-2016·2015-11-04

    Foods R US Recalls Breaded Ravioli for Undeclared Allergens

    Foods R US is recalling Breaded Ravioli due to undeclared soy, milk, and wheat. The product was distributed in California and Arizona.

    Product
    Breaded Ravioli 10 lb. Mfg Foods R Us Scottsdale, AZ 85260 480-951-1883
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0059-2016·2015-11-04

    Moses Lake Pharmacy Recalls Injectable Vitamin and Amino Acid Solution

    Moses Lake Professional Pharmacy is recalling 22 vials of a compounded injectable solution due to a lack of assurance of sterility.

    Product
    B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/5/1/10/25/8/17/17 MG/ML, 30 mM vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0086-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    The FDA is recalling Estradiol Pellets, 6 mg, compounded by JD & SN Inc. because the agency cannot assure the sterility of the product.

    Product
    ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling 6 syringes of Methylcobalamin Injectable Solution due to a lack of assurance of sterility. The recall covers all sterile human compounded drugs within their expiry.

    Product
    METHYLCOBALAMIN MDV, Injectable Solution, 5 MG/ML, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 130 mg testosterone pellets because the company cannot ensure they are sterile.

    Product
    TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0122-2016·2015-11-04

    Moses Lake Pharmacy Recalls Sermorelin Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling 41 syringes of Sermorelin/GHRP-6/GHRP-2 injectable solution because the FDA cannot assure the sterility of the compounded drug.

    Product
    SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide