The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

4426–4450 of 4878

  • SevereFDA (Drugs)·D-0125-2022·2021-11-17

    Methylcobalamin Injectable Recalled for Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling 324 vials of Methylcobalamin 1MG/ML injectable across the United States and Puerto Rico due to lack of assurance of sterility.

    Product
    METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0121-2022·2021-11-17

    Talon Compounding Pharmacy IVME SUPER B Injectable Recalled for Sterility Assurance

    Talon Compounding Pharmacy is recalling IVME SUPER B Injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.

    Product
    IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0161-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Drug Lacks Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable drug containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0097-2022·2021-11-17

    Estradiol Valerate Injection Recalled Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling Estradiol Valerate 20 mg/mL injection vials distributed across the United States, Puerto Rico, and Washington D.C. due to lack of assurance of sterility.

    Product
    Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0195-2022·2021-11-17

    TRI-MIX Injectable Papaverine/Phentolamine/PGE-1 Lacks Sterility Assurance

    Vita Pharmacy (Talon Compounding Pharmacy) is recalling one lot of TRI-MIX injectable medication because the manufacturer cannot assure the product's sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0109-2022·2021-11-17

    CJC-1295/Ipamorelin Injections Recalled Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling CJC-1295 and Ipamorelin injectable vials distributed across the United States because the manufacturer cannot assure sterility of the products.

    Product
    CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0194-2022·2021-11-17

    Tri-Mix Papaverine Injectable from Talon Compounding Pharmacy Recalled

    Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0142-2022·2021-11-17

    Talon Compounding Pharmacy injectable lacks sterility assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (QUAD-MIX) due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0218-2022·2021-11-17

    Compounded TRI-MIX Injectable Recalled for Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ injectable medication due to lack of assurance of sterility. The recall affects vials distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0106-2022·2021-11-17

    B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns

    Talon Compounding Pharmacy is recalling B Complex Injectable (Lot 07192021:91) due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0165-2022·2021-11-17

    Injectable testosterone and dutasteride recalled for lack of sterility assurance

    Talon Compounding Pharmacy is recalling 21 vials of injectable testosterone cypionate/dutasteride because the manufacturer cannot assure sterility of the product. The recall affects distribution across the United States, Washington D.C., and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0172-2022·2021-11-17

    Testosterone Cypionate Anastrozole Injectable Recalled for Sterility Concerns

    Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product due to lack of assurance of sterility. The recall affects nine vials distributed across the United States.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0219-2022·2021-11-17

    TRI-MIX Papaverine Injectable Recalled for Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 injectable medication due to lack of assurance of sterility.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0111-2022·2021-11-17

    Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0170-2022·2021-11-17

    Testosterone Cypionate and Anastrozole Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy (Talon Compounding Pharmacy) is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL injectable in oil due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0155-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Sterility Assurance Recall

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects units distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0144-2022·2021-11-17

    Sermorelin Acetate and Ipamorelin Injection Recall – Sterility Assurance

    Talon Compounding Pharmacy is recalling Sermorelin Acetate 6mg/Ipamorelin 6mg lyophilized vials due to lack of assurance of sterility. The affected product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0107-2022·2021-11-17

    BI-MIX Papaverine/Phentolamine Injectable Recalled for Sterility Assurance

    Talon Compounding Pharmacy is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0197-2022·2021-11-17

    TRI-MIX Injectable Medication Recalled for Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of TRI-MIX PAPAVERINE/PHENTOLAMINE/PGE-1 injectable due to lack of assurance of sterility. The affected vial was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0203-2022·2021-11-17

    TRI-MIX Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 injectable vials distributed nationwide due to lack of assurance of sterility.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0150-2022·2021-11-17

    Compounded Injectable Steroids Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0184-2022·2021-11-17

    Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable vials because the manufacturer cannot assure that the product is sterile. The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0108-2022·2021-11-17

    Compounded Injectable Injection Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme injectable (with Methylcobalamin) due to lack of assurance of sterility. The product was distributed in the United States.

    Product
    BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0225-2022·2021-11-17

    TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication because the manufacturer cannot assure sterility of the product. The recall affects one lot distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0177-2022·2021-11-17

    Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance Lack

    Talon Compounding Pharmacy is recalling testosterone cypionate and anastrozole injectable medication because the manufacturer cannot assure the products were manufactured under sterile conditions. Affected patients should consult their healthcare provider.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states