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.

4401–4425 of 4878

SevereFDA (Drugs)·D-0140-2022·2021-11-17
Quad-Mix Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Quad-Mix Papav 30/Phentol 2/PGE-1 30/Atropine 0.2 injectable medication due to lack of assurance of sterility. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Product
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/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-0147-2022·2021-11-17
TRI-TEST 200 Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-TEST 200 injectable medication due to lack of assurance of sterility. Affected lots include T1007302021:37 and T1008242021:04.
Product
TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/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-0138-2022·2021-11-17
Compounded Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ injectable due to lack of assurance of sterility.
Product
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0135-2022·2021-11-17
Talon Compounding Pharmacy Injectable Drug Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ due to lack of assurance of sterility. The recall affects one lot distributed across the United States, Washington D.C., and Puerto Rico.
Product
QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/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-0211-2022·2021-11-17
Tri-Mix Papaverine Injectable Vials Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable vials due to lack of assurance of sterility. The product was distributed in the United States, Washington D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
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
0 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
0 states
SevereFDA (Drugs)·D-0185-2022·2021-11-17
TRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling TRI-MIX injectable medication because the manufacturer cannot assure that the product meets sterility requirements. Affected patients should consult their healthcare provider immediately.
Product
TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/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-0100-2022·2021-11-17
Alprostadil Injectable Recalled Due to Lack of Sterility Assurance
Vita Pharmacy, LLC (dba Talon Compounding Pharmacy) is recalling Alprostadil 22 mcg/mL injectable due to lack of assurance of sterility. The affected lot was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Product
ALPROSTADIL 22MCG/ML 22MCG/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-0132-2022·2021-11-17
MIC B12 and L-Carnitine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B12 25/50/50/0.5MG/ML L-Carnitine 250MG/ML Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/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-0154-2022·2021-11-17
Talon Compounding Pharmacy Injectable Sterility Recall
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/ml injectable (4 vials) due to lack of assurance of sterility.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #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-0191-2022·2021-11-17
Tri-Mix Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 18/Phentol 0.6/PGE-1 5.88/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 18/PHENTOL 0.6/PGE-1 5.88/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-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
0 states
SevereFDA (Drugs)·D-0102-2022·2021-11-17
Alprostadil 30mcg/ml Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 30mcg/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
ALPROSTADIL 30MCG/ML INJ 30MCG/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-0136-2022·2021-11-17
Quad-Mix Injectable Compound Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (Quad-Mix Papav 30/Phentol 1/PGE-1 10/Atropine 0.15) due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.
Product
QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0169-2022·2021-11-17
Bobo's Almond Butter Protein Bars recalled for undeclared peanuts
Simply Delicious, Inc. is recalling Bobo's Almond Butter Protein Bars (2.2 oz.) because they contain undeclared peanuts, posing a risk to consumers with peanut allergies.
Product
Bobo's Almond Butter Protein Bar, 2.2 oz., 4-pack Multipack, Master Case with 6 sleeves. UPC 8-29262-00201-6 (Individual bar) UPC 8-29262-00326-6 (4-Pack Multipack) UPC 8-29262-00370-9 (Master Case of 6 sleeves) Storage ambient.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0127-2022·2021-11-17
MIC/B Complex/Chromium/Carnitine Injectable Recalled for Sterility Concerns
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable drug product due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/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-0145-2022·2021-11-17
Sermorelin Acetate and Ipamorelin Vials Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 9mg/Ipamorelin 9mg lyophilized vials (Lot 08102021:22) distributed in the United States due to lack of assurance of sterility.
Product
SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0182-2022·2021-11-17
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 25mg/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 25MG/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-0187-2022·2021-11-17
Tri-Mix Papaverine Injectable Lacks Assured Sterility, Talon Compounding
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable medication because the manufacturer lacks assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 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-0199-2022·2021-11-17
TRI-MIX Injectable Compounded Drug Lacks Assured Sterility
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 injectable vials because the manufacturer cannot assure sterility of the product.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/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 (Food)·F-0121-2022·2021-11-17
Sundelight Golden Raisins Recalled for Undeclared Sulfites
Best Foods NJ, Inc. is recalling Sundelight Golden Raisins due to undeclared sulfites. The product was distributed to retail stores in Maryland, New Jersey, and New York.
Product
Sundelight Golden Raisins Net Wt 7oz. UPC: 14760 84059. Plastic pouches. 20 pouches/per case
Category
Food
Distribution
3 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
0 states
SevereFDA (Drugs)·D-0171-2022·2021-11-17
Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product because the manufacturer cannot assure sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/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-0101-2022·2021-11-17
Alprostadil Injectable Recall: Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Alprostadil 25 mcg/mL injectable vials distributed across the United States due to lack of assurance of sterility, which could pose a health risk to patients.
Product
ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states