Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,417
Critical: 3
Severe: 1,048
Most recent: 2026-07-29

Of the 1,417 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 1,048 (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 1417

SevereFDA (Drugs)·D-0175-2022·2021-11-17
Testosterone Cypionate Injectable Compounded Injection Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 1.5mg/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 200MG/ANASTROZOLE 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-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-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-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-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-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-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-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-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
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-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-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
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-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
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
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
SevereFDA (Drugs)·D-0742-2021·2021-08-25
Teva Alprostadil Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Product
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0732-2021·2021-08-25
Haloperidol Decanoate Injection recalled due to sterility concerns
Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.
Product
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0738-2021·2021-08-25
Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0731-2021·2021-08-25
Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
Product
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0737-2021·2021-08-25
Leucovorin Calcium Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2021·2021-08-25
FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.
Product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Category
Medical Device
Distribution
Distributed nationwide