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.

7501–7525 of 29121

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
2 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
2 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
2 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-0110-2022·2021-11-17
Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL Injectable due to lack of assurance of sterility. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Product
ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 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
2 states
SevereFDA (Drugs)·D-0181-2022·2021-11-17
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 20 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
TESTOSTERONE CYPIONATE 20MG/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
2 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
2 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
2 states
SevereFDA (Drugs)·D-0112-2022·2021-11-17
Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL injectable across the United States due to lack of assurance of sterility. The affected product was distributed in 11 vials with multiple lot numbers.
Product
ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 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
2 states
SevereNHTSA·21V893000·2021-11-17
Motorhome seat belt retractor defect affects child restraint systems
Jayco recalls certain 2021-2022 motorhomes with defective seat belt retractors that may fail to secure child restraint systems during crashes. Dealers will replace the retractors free of charge.
Product
JAYCO — JAYCO, ENTEGRA SWIFT, ETHOS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0158-2022·2021-11-17
Injectable Steroid Combination Product Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects lot T1009092021:19 distributed across the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 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
2 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
2 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
2 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
2 states
SevereFDA (Drugs)·D-0152-2022·2021-11-17
Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a testosterone cypionate injectable combination product due to lack of assurance of sterility. The product was distributed in the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0173-2022·2021-11-17
Injectable testosterone cypionate/anastrozole lacks sterility assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling injectable testosterone cypionate 200mg/anastrozole 0.75mg/ml due to lack of assurance of sterility. The recall affects specific lots distributed across the United States, Washington D.C., and Puerto Rico.
Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 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
2 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
2 states
SevereFDA (Drugs)·D-0200-2022·2021-11-17
Tri-Mix Papaverine Injectable Lacks Assurance of Sterility
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable due to lack of assurance of sterility. The product was distributed in the United States, including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0189-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 15/Phentolamine 2/PGE-1 20 Injectable due to lack of assurance of sterility. The recalled product was distributed throughout the United States including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0224-2022·2021-11-17
TRI-MIX Injectable Papaverine Phentolamine PGE-1 Lacks Sterility Assurance
Vita Pharmacy (Talon Compounding) is recalling TRI-MIX injectable medication (Lot 07142021:43) distributed across the United States because the manufacturer cannot assure the product meets sterility standards.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 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
2 states