Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,691
Critical: 12
Severe: 931
Most recent: 2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 sterility failure 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.

426–450 of 1691

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
2 states
SevereFDA (Drugs)·D-0215-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 2/PGE-1 60 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 2/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-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
2 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
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-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 (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
2 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
2 states
HighFDA (Drugs)·D-0130-2022·2021-11-17
Talon Compounding Pharmacy Injectable MIC B Complex Sterility Recall
Talon Compounding Pharmacy is recalling MIC B Complex with Chromium/Methylcobalamin injectable (Lot 09022021:50) due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Product
MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) 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-0103-2022·2021-11-17
Alprostadil injectable recalled due to lack of sterility assurance
Vita Pharmacy LLC (dba Talon Compounding Pharmacy) is recalling Alprostadil 32 mcg/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
ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0134-2022·2021-11-17
Progesterone Injectable Recalled Due to Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Progesterone 100mg/mL Injectable because the manufacturer cannot assure the product meets sterility requirements. The recall affects one vial distributed across the United States.
Product
PROGESTERONE 100MG/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
HighFDA (Drugs)·D-0208-2022·2021-11-17
TRI-MIX Injectable Medication Recalled Due to Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ injectable medication because the manufacturer lacks assurance of sterility.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/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-0167-2022·2021-11-17
Injectable Compounded Drug Recall: Sterility Assurance Failure
Vita Pharmacy, LLC (Talon Compounding Pharmacy) is recalling Test Cypionate 200mg/Dutasteride 2mg/mL injectable due to lack of sterility assurance. The affected lot was distributed across the United States.
Product
TEST CYPIONATE 200MG/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
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-0037-2022·2021-11-03
Estradiol Valerate Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.
Product
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0004-2022·2021-10-13
Betaxolol Ophthalmic Solution Recalled for Sterility Failure
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
Product
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Category
Drug
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-2378-2021·2021-09-08
Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure
Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.
Product
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2379-2021·2021-09-08
Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure
Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.
Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0736-2021·2021-08-25
Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
Product
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0733-2021·2021-08-25
Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
Product
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0730-2021·2021-08-25
DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.
Product
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0740-2021·2021-08-25
Adenosine Injection Vials Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
Product
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0702-2021·2021-08-11
Succinylcholine Chloride Syringes Recalled for Lack of Sterility Assurance
BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.
Product
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2077-2021·2021-07-21
Urethral bulking system needles recalled due to sterility assurance failure
Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.
Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Category
Medical Device
Distribution
Distributed nationwide