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.

4376–4400 of 4878

  • SevereFDA (Drugs)·D-0216-2022·2021-11-17

    Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 3/PGE-1 100 injectable due to lack of assurance of sterility. The affected lot was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 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-0198-2022·2021-11-17

    Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable 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 30/PHENTOLAMINE 0.25/PGE-1 6 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-0201-2022·2021-11-17

    TRI-MIX PAPAVERINE Injectable from Talon Compounding Pharmacy Recalled

    Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 injectable medication due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 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-0141-2022·2021-11-17

    Talon Compounding Pharmacy Quad-Mix Injectable Lacks Sterility Assurance

    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, Washington D.C., and Puerto Rico.

    Product
    QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/ATROPINE 0.2 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-0105-2022·2021-11-17

    Alprostadil 45mcg/mL Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 45mcg/mL injectable due to lack of assurance of sterility. The affected product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    ALPROSTADIL 45MCG/ML 45MCG/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-0156-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Drug Recalled for Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable combination drug (Lot T1008312021:33) due to lack of assurance of sterility. The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/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-0159-2022·2021-11-17

    Talon Compounding Injectable Sterility Recall

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable steroid combination product due to lack of assurance of sterility. The recall affects 13 vials distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/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-0207-2022·2021-11-17

    TRI-MIX Injectable Compounded Drug Recalled for Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 injectable medication 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 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0157-2022·2021-11-17

    Injectable Compounded Hormone and Steroid Product Lacks Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable compounded drug product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/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-0179-2022·2021-11-17

    Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL injectable vials distributed across the United States due to lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE 200MG/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-0223-2022·2021-11-17

    TRI-MIX Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/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-0175-2022·2021-11-17

    Testosterone Cypionate Injectable Compounded Injection Lacks Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 1.5mg/mL injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/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-0162-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Steroid Mixture Recall for Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable anabolic steroid mixture (Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 2mg/mL in oil) due to lack of assurance of sterility. The recall affects products distributed throughout the United States.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/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-0114-2022·2021-11-17

    Estradiol Valerate Injection Recall Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling Estradiol Valerate 50mg/ml Injectable (Lot 09162021:22) distributed across the United States because the manufacturer cannot assure the product's sterility.

    Product
    ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0128-2022·2021-11-17

    MIC/B Complex/Chrom/Carn/Lido Injectable Lacks Sterility Assurance

    Talon Compounding Pharmacy is recalling one lot of MIC/B Complex/Chrom/Carn/Lido Injectable (Lot 07292021:73, BUD 10/30/2021) distributed nationwide due to lack of assurance of sterility. Patients who received this injectable product should consult their healthcare provider.

    Product
    MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0131-2022·2021-11-17

    MIC B Complex Injectable Compounded Drug Recall for Sterility Assurance

    Talon Compounding Pharmacy is recalling MIC B Complex with Hydroxocobalamin 5MG/ML injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.

    Product
    MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/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-0098-2022·2021-11-17

    Injectable Diet Aid Product Recalled for Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling Well's Lipo-Lean injectable vials (Lot 08062021:30) due to lack of assurance of sterility. The product is distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0122-2022·2021-11-17

    Mushroom Stir Fry Blend Recalled for Listeria monocytogenes

    Taylor Farms Tennessee is recalling 314 units of Mushroom Stir Fry Blend due to positive Listeria monocytogenes detected in random sampling. The affected product was distributed to Kroger locations in eight states.

    Product
    Mushroom Stir Fry Blend 9oz container sold individually
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0137-2022·2021-11-17

    Talon Compounding Pharmacy Quad-Mix Injectable Lacks Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 injectable due to lack of assurance of sterility. The affected product was distributed in the United States including Washington, D.C. and Puerto Rico.

    Product
    QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 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-0117-2022·2021-11-17

    Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 1,000 MCG/mL injectable vials due to lack of assurance of sterility. The affected lot was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/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-0164-2022·2021-11-17

    Injectable Steroid Combination Recalled Due to Sterility Assurance

    Talon Compounding Pharmacy is recalling an injectable steroid combination product (Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 2mg/mL) due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/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-0190-2022·2021-11-17

    TRI-MIX Papaverine Injectable Recalled Due to Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 injectable due to lack of assurance of sterility.

    Product
    TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0160-2022·2021-11-17

    Injectable Steroid Compound Recalled Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling a testosterone cypionate combination injectable product distributed nationwide due to lack of assurance of sterility, which could pose risk of serious infection.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/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 (Devices)·Z-0183-2022·2021-11-17

    Ellume COVID-19 Home Test Recalled for Higher Rate of False Positives

    Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.

    Product
    Ellume COVID-19 Home Test
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0204-2022·2021-11-17

    Tri-Mix Injectable Compounded Drug Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 injectable vials distributed across the United States and Puerto Rico due to lack of assurance of sterility.

    Product
    TRI-MIX PAPAVERINE 30/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