Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,423
Critical: 3
Severe: 1,055
Most recent: 2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) 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 lack of sterility 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.

401–425 of 1423

SevereFDA (Drugs)·D-0108-2022·2021-11-17
Compounded Injectable Injection Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme injectable (with Methylcobalamin) due to lack of assurance of sterility. The product was distributed in the United States.
Product
BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0225-2022·2021-11-17
TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication because the manufacturer cannot assure sterility of the product. The recall affects one lot distributed across the United States, Washington, D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 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-0170-2022·2021-11-17
Testosterone Cypionate and Anastrozole Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy (Talon Compounding Pharmacy) is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL injectable in oil due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/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-0107-2022·2021-11-17
BI-MIX Papaverine/Phentolamine Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States, Washington D.C., and Puerto Rico.
Product
BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 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-0194-2022·2021-11-17
Tri-Mix Papaverine Injectable from Talon Compounding Pharmacy Recalled
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ 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 23.3/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-0106-2022·2021-11-17
B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling B Complex Injectable (Lot 07192021:91) due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Product
B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0115-2022·2021-11-17
Estradiol Valerate Injectable Recalled Due to Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable across the United States, Washington D.C., and Puerto Rico due to lack of assurance of sterility.
Product
ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/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-0163-2022·2021-11-17
Injectable steroid compound recalled due to lack of sterility assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable pharmaceutical compound containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects one lot distributed in the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 2MG/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
HighFDA (Drugs)·D-0119-2022·2021-11-17
IC B Complex Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling IC B Complex Injectable due to lack of assurance of sterility. The affected vial lot 09152021:12 was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
IC B COMPLEX 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-0210-2022·2021-11-17
TRI-MIX PAPAVERINE Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 Injectable due to lack of assurance of sterility. The recalled product was distributed in the United States including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 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-0212-2022·2021-11-17
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 30 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 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-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-0153-2022·2021-11-17
Injectable anabolic steroid compound recalled for lack of sterility assurance
Talon Compounding Pharmacy is recalling an injectable testosterone cypionate compound because the manufacturer cannot assure the product is sterile. The affected vials were distributed across the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/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
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
SevereFDA (Drugs)·D-0039-2022·2021-11-03
Hydroxyprogesterone Caproate Injection Recalled Due to Sterility Concerns
First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.
Product
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0044-2022·2021-11-03
TEST CYP 200MG/ML injection recalled due to sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Product
TEST CYP 200MG/ML MDV ETHYL OLEATE, 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
HighFDA (Drugs)·D-0054-2022·2021-11-03
Acetylcysteine 2% Ophthalmic Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 2% Ophthalmic Solution due to lack of assurance of sterility. The FDA identified concerns during an inspection of the manufacturing facility.
Product
ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Drugs)·D-0051-2022·2021-11-03
Vitamin B Complex Injectable Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injectable Solution (HP) due to lack of assurance of sterility raised during FDA inspection. Approximately 494 patients across seven states received affected prescriptions.
Product
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
HighFDA (Drugs)·D-0041-2022·2021-11-03
Pyridoxine HCL Injection Recalled for Lack of Sterility Assurance
Red Mountain Compounding Pharmacy is recalling pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple states received affected prescriptions.
Product
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Food)·F-0012-2022·2021-10-20
Fairlife Milk 8oz 6-Pack Chocolate Recalled for Spoilage Risk
Fairlife Llc is recalling Fairlife Milk 8oz 6-pack chocolate bottles with date code MAY2722 FA due to potential spoilage and lack of commercial sterility. The affected product was distributed to retailers in Arizona, California, Oregon, Utah, Washington, and military distributors.
Product
FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; Unit UPC 008-11620-02206-4
Category
Food
Distribution
5 states
SevereFDA (Drugs)·D-0896-2021·2021-10-06
ceFAZolin Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.
Product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0820-2021·2021-09-29
Fulvestrant Injection Recall: Lack of Sterility Assurance
Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.
Product
FULVESTRANT — FULVESTRANT (FULVESTRANT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0768-2021·2021-09-01
SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Category
Drug
Distribution
Distributed nationwide