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.

15676–15700 of 29205

  • SevereFDA (Food)·F-2951-2017·2017-08-02

    Dierbergs Santa Fe Grilled Chicken Wrap Recalled for Undeclared Milk

    Dierbergs Markets is recalling Santa Fe Grilled Chicken Wraps because they contain undeclared milk, a major food allergen.

    Product
    Dierbergs Kitchen, Santa Fe Grilled Chicken Wrap, NET WT. 11 oz, UPC 0 231789 804996
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1028-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Phenylephrine 100 mg injection bags because they lack assurance of sterility and may leak.

    Product
    PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1004-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling two bags of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak.

    Product
    PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1031-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine 50 mg injection due to a lack of assurance of sterility and potential for product leakage.

    Product
    PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2017·2017-08-02

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling ePHEDrine Sulfate syringes due to a lack of assurance of sterility and potential for leaking.

    Product
    ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1003-2017·2017-08-02

    SCA Pharmaceuticals Recalls Magnesium Sulfate Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate 4 g in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak, compromising sterility.

    Product
    MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL bags because they may leak and lack assurance of sterility.

    Product
    PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1020-2017·2017-08-02

    SCA Pharmaceuticals Recalls NORepinephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.

    Product
    NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1026-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine 10 mg IV bags due to a lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1002-2017·2017-08-02

    SCA Pharmaceuticals Recalls Diltiazem Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Diltiazem 125 mg injection bags because they were made with recalled saline bags that may leak, compromising sterility.

    Product
    Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2017·2017-08-02

    SCA Pharmaceuticals Recalls Repinephrine Bitartrate Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for product leakage.

    Product
    NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V486000·2017-08-02

    CSI Recalls 2013-2016 Wildland Units Due to Wheel Cracking

    CSI Emergency Apparatus is recalling 2013-2016 Wildland Emergency vehicles because Stazworks wheels may crack and break, potentially causing a crash.

    Product
    CSI — CSI WILDLAND UNIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1027-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1010-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl citrate syringes due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1006-2017·2017-08-02

    SCA Pharmaceuticals Recalls Bupivacaine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Bupivacaine HCl 0.125% bags due to a lack of assurance of sterility and potential for leaking.

    Product
    BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1030-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Phenylephrine 20 mg IV bags due to a lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1023-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine HCl Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl injection because the product lacks assurance of sterility and has the potential to leak.

    Product
    PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2017·2017-08-02

    SCA Pharmaceuticals Recalls Potassium Chloride Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL due to lack of assurance of sterility and potential for leaking.

    Product
    Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·087-2017·2017-08-02

    Bateman Recalls Poultry Products Due to Undeclared Soy Allergen

    Bateman is recalling approximately 20,638 pounds of ready-to-eat poultry products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Bateman Recalls Poultry Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1015-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags because they may leak and lack assurance of sterility.

    Product
    fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
    Category
    Drug
    Distribution
    Distributed nationwide