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.

301–325 of 1417

HighFDA (Drugs)·D-1263-2022·2022-07-27
Lidocaine HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center recalls Lidocaine HCl Injection 2% syringes distributed nationwide due to lack of assurance of sterility. Affected lots should not be used.
Product
Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1247-2022·2022-07-27
Bupivacaine Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 6900 syringes of Bupivacaine HCl Injection nationwide due to lack of sterility assurance. No illnesses or injuries have been reported.
Product
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1270-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1208-2022·2022-07-20
Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution nationwide due to lack of assurance of sterility. Consumers should not use affected batches.
Product
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1205-2022·2022-07-20
Glutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues
Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
Product
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1199-2022·2022-07-20
Dexpanthenol injectable vials recalled for lack of sterility assurance
Tailor Made Compounding is recalling 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates were distributed nationwide in the USA and Puerto Rico.
Product
Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1197-2022·2022-07-20
Biotin 5mg/mL injection recalled for lack of sterility assurance
Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.
Product
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1204-2022·2022-07-20
Compounded Injectable Amino Acid Drug Recalled for Sterility Assurance Issues
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
Product
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1217-2022·2022-07-20
Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.
Product
Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1210-2022·2022-07-20
Compounded injectable product recalled for lack of sterility assurance
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
Product
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1211-2022·2022-07-20
Levocarnitine Injection Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
Product
Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1226-2022·2022-07-20
Sermorelin Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.
Product
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1214-2022·2022-07-20
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
Product
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1240-2022·2022-07-20
Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
Product
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1241-2022·2022-07-20
Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.
Product
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1219-2022·2022-07-20
NAD+ Injectable Vials Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Product
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1235-2022·2022-07-20
Testosterone Injections Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.
Product
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1224-2022·2022-07-20
Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.
Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1221-2022·2022-07-20
Injectable Drug Pentosan Polysulfate Sodium Recalled for Sterility Assurance
Tailor Made Compounding is recalling 220 vials of Pentosan Polysulfate Sodium due to lack of assurance of sterility. The affected batches were distributed nationwide in the United States and Puerto Rico.
Product
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1200-2022·2022-07-20
Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Product
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1206-2022·2022-07-20
Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.
Product
Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1225-2022·2022-07-20
Compounded Semaglutide/Cyanocobalamin Vials Recalled Over Sterility Concerns
Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.
Product
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1216-2022·2022-07-20
Methylcobalamin 1mg/mL Vials Recalled for Lack of Sterility Assurance
TMC Acquisition LLC recalls 191 vials of Methylcobalamin 1mg/mL distributed nationwide and in Puerto Rico due to lack of sterility assurance. Consult your healthcare provider regarding any vials in your possession.
Product
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1228-2022·2022-07-20
Sermorelin/Glycine Injectable Recalled for Lack of Sterility Assurance
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
Product
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0987-2022·2022-06-15
B-Complex plus Chromic Chloride injection recall for lack of sterility assurance
US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.
Product
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations
Category
Drug
Distribution
Distributed nationwide