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.

21251–21275 of 32121

  • SevereFDA (Devices)·Z-0230-2016·2015-11-25

    Event Medical Recalls Inspiration Ventilators Due to Power Board Failure

    Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.

    Product
    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-329-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0227-2016·2015-11-25

    Maplehurst German Chocolate Cakes Recalled for Incorrect Allergen Labeling

    Maplehurst Bakeries is recalling German Chocolate Layer Cakes sold at Publix in Florida and Georgia because the labels listed ingredients for a different product.

    Product
    7" Publix Bakery - German Chocolate Layer Cake. Product is shipped in cases containing 6 individual cakes.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-328-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL injection because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2016·2015-11-25

    US Compounding Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

    US Compounding Inc is recalling Phenylephrine 10% PF Ophthalmic Solution because deficient practices may have impacted sterility assurance.

    Product
    Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0277-2016·2015-11-25

    Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk

    Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.

    Product
    Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-324-2016·2015-11-25

    Sermorelin Injection Recalled Due to Lack of Sterility Assurance

    Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0269-2016·2015-11-25

    US Compounding Recalls MIC-Combo Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 1,736 vials of MIC-Combo injection due to deficient practices that may impact sterility assurance.

    Product
    MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2016·2015-11-25

    US Compounding Recalls Dex Combo Sterile Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.

    Product
    Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0284-2016·2015-11-25

    US Compounding Recalls Triamcinolone Acetonide Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-304-2016·2015-11-25

    Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-303-2016·2015-11-25

    Essential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.

    Product
    Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0196-2016·2015-11-25

    Martinelli's Sparkling Red Grape Recalled for Potential Glass Fragments

    S. Martinelli & Co is recalling Martinelli's Sparkling Red Grape due to the potential for glass fragments in the bottles.

    Product
    Martinelli's Sparkling Red Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99926 2; item number 99926; 4/6 packs, Tray UPC 0 41244-64926 6, item number 64926 6 pack retail UPC 0 41244-64026 3. Single 8.4 oz. bottle - UPC 0 41244 99026 9.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-307-2016·2015-11-25

    FDA Recalls HCG and Lidocaine Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling HCG 1000 U/LIDO 0.2% Injection vials due to poor sterile production practices that compromised sterility assurance.

    Product
    HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2016·2015-11-25

    US Compounding Recalls Triamcinolone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0216-2016·2015-11-25

    Vaughan Foods Recalls Sliced Cucumbers Due to Salmonella Contamination Risk

    Vaughan Foods is recalling specific packages of sliced cucumbers due to a potential risk of Salmonella contamination. The products were distributed in six states.

    Product
    Sliced Cucumbers (100/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Sliced Cucumbers (50/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; CU-2-Sliced Cucumbers (1/5 LB Tub) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-305-2016·2015-11-25

    Essential Wellness Pharma Recalls Glycerin Opth Solution Due to Sterility Concerns

    Kalman Health & Wellness is recalling Glycerin Opth Solution because poor sterile production practices may have compromised the sterility of the finished drug.

    Product
    Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-334-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #3 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0230-2016·2015-11-25

    Kanan Enterprises Recalls Cashews and Sweeties for Undeclared Milk

    Kanan Enterprises is recalling 14-ounce bags of Kings fresh & Delicious Cashews & Sweeties because the product contains undeclared milk.

    Product
    Kings fresh & Delicious Cashews & Sweeties Net Wt. 14oz. (397g) INGREDIENTS: Cashews (Cashews, Canola and/or Peanut Oil Salt), CHOCOLATE BUTTONS (Sugar, Partially Hydrogenated Palm Kernel***King Nut Companies Solon, OH 44139 www.kingnut.com 0 38445 49999 8
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-0284-2016·2015-11-25

    Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure

    FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.

    Product
    Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2016·2015-11-25

    US Compounding Recalls L-Cysteine PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,706 vials of L-Cysteine PF due to deficient practices that may impact sterility assurance.

    Product
    L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2016·2015-11-25

    Solutions Rx Pharmacy Recalls Budesonide Capsules Due to Penicillin Contamination

    Solutions Rx Pharmacy is recalling compounded budesonide nasal rinse capsules due to possible penicillin cross-contamination in the bulk powder.

    Product
    c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0244-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Trop PF Eye Drops for Sterility Concerns

    US Compounding Inc is recalling 135 bottles of Cyclo/PE/Trop PF eye drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2016·2015-11-25

    US Compounding Recalls Pilocarpine Ophthalmic Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.

    Product
    Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    Category
    Drug
    Distribution
    Distributed nationwide