Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,438
Critical: 25
Severe: 993
Most recent: 2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all infection risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

976–1000 of 3438

HighFDA (Drugs)·D-0166-2022·2021-11-17
Injectable testosterone and dutasteride product recall for sterility assurance failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Dutasteride 1mg/ml Injectable due to lack of assurance of sterility. Affected lots include T1008312021:02 and T1007142021:62.
Product
TEST CYPIONATE 200MG/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
HighFDA (Drugs)·D-0217-2022·2021-11-17
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 30 injectable due to lack of assurance of sterility. The product was distributed across the United States.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0196-2022·2021-11-17
Tri-Mix Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 25MG/Phentolamine 1MG/PGE1 25MCG/ML Injectable due to lack of assurance of sterility.
Product
TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0120-2022·2021-11-17
IVME HCG Vitamin B Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling IVME HCG Vitamin B injectable in the United States due to lack of assurance of sterility. The product was distributed as a prescription-only injectable.
Product
IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0226-2022·2021-11-17
TRI-MIX PAPAVERINE Injectable Recall: Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/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
HighFDA (Drugs)·D-0099-2022·2021-11-17
Alprostadil Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 22.5mcg/mL 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
ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-0184-2022·2021-11-10
Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Category
Medical Device
Distribution
40 states
SevereFDA (Drugs)·D-0066-2022·2021-11-03
Progesterone 100mg/ml Oil Injection Recall: Sterility Assurance Defect
Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.
Product
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0057-2022·2021-11-03
Folic Acid 10mg/mL Injectable Recalled Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling folic acid injectable medication because the FDA found the product lacks adequate sterility assurance. The recall affects prescriptions distributed across multiple states.
Product
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0063-2022·2021-11-03
MIC/B12A Injectable Compounded Drug Recall for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.
Product
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0059-2022·2021-11-03
Methylcobalamin Injectable: Sterility Assurance Deficiency
Red Mountain Compounding Pharmacy is recalling methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.
Product
METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0031-2022·2021-11-03
Ascorbic Acid Solution Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.
Product
ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Drugs)·D-0043-2022·2021-11-03
Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.
Product
TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Drugs)·D-0049-2022·2021-11-03
Red Mountain Compounding Pharmacy Testosterone Blend Injection Sterility Recall
Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.
Product
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Drugs)·D-0056-2022·2021-11-03
Calcium Gluconate 10% Injectable Recalled for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.
Product
CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Devices)·Z-0146-2022·2021-10-27
Herniatome Surgical Instrument Recalled Due to Sterilization Process Failure
ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.
Product
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0145-2022·2021-10-27
Herniatome lumbar surgical instrument recalled for sterilization failure
ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.
Product
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Category
Medical Device
Distribution
2 states
ModerateFDA (Drugs)·D-0018-2022·2021-10-27
Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Product
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0028-2022·2021-10-13
FDA Recalls TECNIS Eyhance Intraocular Lenses for Elevated Endotoxin
Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.
Product
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0897-2021·2021-10-06
ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.
Product
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
Category
Drug
Distribution
3 states
HighFDA (Devices)·Z-2545-2021·2021-10-06
B. Braun Outlook Pump Sets recalled for potential leakage and infection risk
B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-delivery and increase bloodstream infection risk.
Product
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2552-2021·2021-10-06
B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.
Product
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2565-2021·2021-10-06
Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated
Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.
Product
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2560-2021·2021-10-06
Blood Administration Pump Set Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.
Product
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2569-2021·2021-10-06
Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
Product
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
Category
Medical Device
Distribution
Distributed nationwide