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.

401–425 of 1691

SevereFDA (Drugs)·D-0321-2022·2022-01-05
SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0316-2022·2022-01-05
SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0319-2022·2022-01-05
SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0301-2022·2022-01-05
SterRx Morphine Sulfate Injection Recalled for Sterility Assurance
SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.
Product
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0324-2022·2022-01-05
SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure
SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.
Product
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0262-2022·2021-12-08
Ascorbic Acid Injection Recalled Due to Lack of Sterility Assurance
ASP CARES is recalling Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL vials) distributed in the United States because the manufacturer cannot assure the product meets sterility requirements.
Product
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0260-2022·2021-12-08
Methylcobalamin Solution for Injection Recalled for Sterility Risk
ASP Cares is recalling Methylcobalamin Solution for Injection due to lack of assurance of sterility. The recall affects one lot distributed in the United States.
Product
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0218-2022·2021-11-17
Compounded TRI-MIX Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ injectable medication due to lack of assurance of sterility. The recall affects vials distributed across the United States, including Washington, D.C. and Puerto Rico.
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-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-0169-2022·2021-11-17
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling testosterone cypionate 100 mg/mL injectable in 12 lots due to lack of assurance of sterility. The affected product was distributed across the United States.
Product
TESTOSTERONE CYPIONATE 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
SevereFDA (Drugs)·D-0097-2022·2021-11-17
Estradiol Valerate Injection Recalled Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Estradiol Valerate 20 mg/mL injection vials distributed across the United States, Puerto Rico, and Washington D.C. due to lack of assurance of sterility.
Product
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0198-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable 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 0.25/PGE-1 6 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-0174-2022·2021-11-17
Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy (Talon Compounding Pharmacy) is recalling two lots of testosterone cypionate 200mg/anastrozole 0.7mg/ml injectable solution due to lack of assurance of sterility. The product was distributed nationwide.
Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/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-0143-2022·2021-11-17
Sermorelin Acetate/Ipamorelin Vials Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
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-0098-2022·2021-11-17
Injectable Diet Aid Product Recalled for Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Well's Lipo-Lean injectable vials (Lot 08062021:30) due to lack of assurance of sterility. The product is distributed across the United States, Washington D.C., and Puerto Rico.
Product
(WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0214-2022·2021-11-17
TRI-MIX Injectable Compounded Drug Recalled for Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 injectable medication due to lack of assurance of sterility. The recall affects vials distributed throughout the United States.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 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-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-0189-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 15/Phentolamine 2/PGE-1 20 Injectable due to lack of assurance of sterility. The recalled product was distributed throughout the United States including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/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-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
SevereFDA (Drugs)·D-0128-2022·2021-11-17
MIC/B Complex/Chrom/Carn/Lido Injectable Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling one lot of MIC/B Complex/Chrom/Carn/Lido Injectable (Lot 07292021:73, BUD 10/30/2021) distributed nationwide due to lack of assurance of sterility. Patients who received this injectable product should consult their healthcare provider.
Product
MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO 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-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-0111-2022·2021-11-17
Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states