Hazard

Sterility Assurance recalls

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

What the numbers show

Total: 663
Critical: 0
Severe: 261
Most recent: 2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) 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 assurance 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.

476–500 of 663

SevereFDA (Drugs)·D-0205-2022·2021-11-17
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 2.5 injectable due to lack of assurance of sterility. The recall affects 30 vials distributed across the United States.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 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-0149-2022·2021-11-17
Vitamin D3 Injectable from Talon Compounding Pharmacy Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling Vitamin D3 100,000 IU/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
VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0152-2022·2021-11-17
Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a testosterone cypionate injectable combination product due to lack of assurance of sterility. The product was distributed in the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/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-0104-2022·2021-11-17
Alprostadil Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 40 mcg/mL injectable vials due to lack of assurance of sterility. The recall affects the U.S. including Washington, D.C. and Puerto Rico.
Product
ALPROSTADIL 40MCG/ML INJ 40MCG/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-0139-2022·2021-11-17
Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ due to lack of assurance of sterility.
Product
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 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-0116-2022·2021-11-17
Talon Compounding Pharmacy Injectable Amino Acid Solution Recall
Talon Compounding Pharmacy is recalling GOAL-GLUTAMINE injectable solution due to lack of assurance of sterility. The affected product was distributed across the United States.
Product
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/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-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-0129-2022·2021-11-17
MIC B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling MIC B Complex INJ-MILES FORMULATION INJECTABLE due to lack of assurance of sterility. The drug is distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
MIC B COMPLEX INJ-MILES FORMULATION 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 (Drugs)·D-0118-2022·2021-11-17
Hydroxocobalamin 5,000 MCG/ML Injectable Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 5,000 MCG/ML Injectable due to lack of assurance of sterility. The affected lot is 08242021:51 with a BUD of 10/23/2021.
Product
HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0213-2022·2021-11-17
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 40 INJ injectable vials due to lack of assurance of sterility.
Product
TRI-MIX PAPAVERINE 30/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
SevereFDA (Drugs)·D-0058-2022·2021-11-03
Methylcobalamin Injectable Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling methylcobalamin 10,000 MCG/ML multi-dose vials after FDA inspection identified sterility assurance concerns.
Product
METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0047-2022·2021-11-03
TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.
Product
TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, 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
SevereFDA (Drugs)·D-0033-2022·2021-11-03
Ascorbic/Glutathione Eye Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.
Product
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0065-2022·2021-11-03
MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Product
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0042-2022·2021-11-03
Red Mountain Compounding Test Cypionate Sterility Assurance Recall
Red Mountain Compounding Pharmacy is recalling Test Cypionate 100MG/ML in Ethyl Oleate Oil due to FDA inspection findings of sterility assurance concerns.
Product
TEST CYP 100MG/ML IN ETHYL OLEATE OIL, 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-0053-2022·2021-11-03
Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.
Product
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0061-2022·2021-11-03
Methylcobalamin Injection Recalled for Sterility Assurance Deficiency
Red Mountain Compounding Pharmacy is recalling Methylcobalamin 5000 mcg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah.
Product
METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0035-2022·2021-11-03
Cyclosporine 2% MCT Oil Suspension Recalled for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.
Product
CYCLOSPORINE 2% MCT OIL SUSP, 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-0038-2022·2021-11-03
Glutathione 200mg/mL MDV Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.
Product
GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0040-2022·2021-11-03
Levocarnitine Injectable Solution Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling levocarnitine 100 mg/mL injectable solution (all lots within expiry) due to FDA inspection findings that raised sterility assurance concerns. Approximately 494 patients in seven states received prescriptions.
Product
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states