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.

21901–21925 of 32121

  • SevereFDA (Drugs)·D-1681-2015·2015-09-23

    FDA Recalls Intrathecal Pain Medication Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a specific intrathecal pain medication solution because an FDA inspection found violations that could affect the product's sterility.

    Product
    Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1804-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-102 Injectable nationwide because an FDA inspection found GMP violations that may affect sterility.

    Product
    Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1743-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 12.5 mg sterile pellets due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1540-2015·2015-09-23

    FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 0.25 mg/ml Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1576-2015·2015-09-23

    Compounded Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling a compounded injection due to FDA-identified GMP violations that impact sterility assurance.

    Product
    Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1728-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2015·2015-09-23

    Cyanocobalamin and B-Complex Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1809-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-50 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1718-2015·2015-09-23

    Quad-Mix 4 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Quad-Mix 4 Injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1603-2015·2015-09-23

    Morphine and Fentanyl Solution Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Fentanyl solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1710-2015·2015-09-23

    FDA Recalls Morphine, Fentanyl, and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile morphine, fentanyl, and bupivacaine solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1539-2015·2015-09-23

    Hyaluronidase Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hyaluronidase 175 units/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1484-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V594000·2015-09-23

    Mitsubishi Mirage and i-MiEV Recalled for Air Bag Deployment Issues

    Mitsubishi is recalling 2014 Mirages and 2012 i-MiEVs because increased resistance in the impact sensor may delay or prevent air bag deployment in a crash.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE, I-MIEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1713-2015·2015-09-23

    FDA Recalls Compounded Sterile Morphine and Fentanyl Solution for Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to FDA-identified GMP violations that may impact sterility.

    Product
    Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1470-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.

    Product
    Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1738-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1592-2015·2015-09-23

    Morphine Solution Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Morphine 25 mg/ml Solution due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1712-2015·2015-09-23

    FDA Recalls Compounded Sterile Anesthesia Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile, preservative-free compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility assurance.

    Product
    Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1784-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1732-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1614-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution nationwide due to FDA inspection findings regarding sterility assurance.

    Product
    Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1760-2015·2015-09-23

    Testosterone Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Tri-Blend injections due to FDA inspection findings regarding sterility assurance and GMP violations.

    Product
    Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1480-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide