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.

12126–12150 of 29164

  • SevereCPSC·19115·2019-05-02

    Excalibur EZ DRY Food Dehydrators Recalled Due to Fire Hazard

    Greenfield World Trade is recalling Excalibur EZ DRY food dehydrators because they can overheat, posing a fire hazard and causing minor burn injuries.

    Product
    Excalibur EZ DRY food dehydrators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1227-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CefTRIAXone Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 15 syringes of CefTRIAXone 1 GM due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1237-2019·2019-05-01

    Vancomycin 1500 mg Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1221-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip due to a lack of sterility assurance. The products were distributed in North Carolina.

    Product
    Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1236-2019·2019-05-01

    Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1231-2019·2019-05-01

    Phenylephrine IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1230-2019·2019-05-01

    Phenylephrine Syringes Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1210-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Clindamycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 1,233 bags of Clindamycin 900 mg in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1224-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM products in North Carolina due to a lack of sterility assurance.

    Product
    CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1215-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1223-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1234-2019·2019-05-01

    Sodium Citrate Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4% due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1217-2019·2019-05-01

    Enterprise Pharmacy Recalls Nifedipine Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 1,783 bags of Nifedipine 25 mg in NS 250 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1220-2019·2019-05-01

    Alteplase Syringes Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1222-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1 for intradermal use due to a lack of sterility assurance.

    Product
    Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1219-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Oxytocin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1228-2019·2019-05-01

    Chlorothiazide Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 60 syringes of Chlorothiazide 100 mg due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1229-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Heparin Pork Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 87 bags of Heparin Pork 30,000 Units in NS 1000 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1225-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 2 GM in bags and syringes due to a lack of sterility assurance. The products were distributed in North Carolina.

    Product
    CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1213-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1235-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1212-2019·2019-05-01

    Labetalol Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 6,667 Labetalol syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1238-2019·2019-05-01

    Vancomycin Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL due to lack of sterility assurance.

    Product
    Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1214-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state