Hazard

Lack Of Sterility recalls

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

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 447

HighFDA (Drugs)·D-0041-2023·2022-11-09
Compounded injectable medication recalled for lack of sterility assurance
Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.
Product
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0015-2023·2022-10-26
Saline Solution Injection Recalled Nationwide Due to Sterility and Leakage
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1545-2022·2022-10-05
Inhalation Drug Recalled Due to Sterility Assurance Failure
Cipla recalls Budesonide Inhalation Suspension ampules due to inability to assure sterility. Affected lots GA20080, GA20081, and GA20094 expire January 2024.
Product
BUDESONIDE — BUDESONIDE (BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1529-2022·2022-09-21
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.
Product
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1517-2022·2022-09-21
Injectable drug product recalled for lack of sterility assurance
Carolina Infusion is recalling MIC/B12/L-Carn (HD) injectable vials due to inability to assure product sterility. The product was distributed nationwide.
Product
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1527-2022·2022-09-21
TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.
Product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1533-2022·2022-09-21
FDA Recalls Injectable Medication Due to Sterility Assurance Failure
Carolina Infusion's QUAD-MIX 30/2/60/0.15 injectable (Lot 08022022@12) is recalled nationwide because the manufacturer failed to assure sterility. Patients and healthcare providers should not use affected vials and should contact the manufacturer.
Product
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1523-2022·2022-09-21
Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns
Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.
Product
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1525-2022·2022-09-21
FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance
Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.
Product
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1331-2022·2022-08-17
FentaNYL Citrate IV solution recalled due to sterility assurance concerns
SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.
Product
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1255-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1278-2022·2022-07-27
Compounded Sterile Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling 2210 syringes of a three-drug compounded injectable due to lack of assurance of sterility.
Product
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1245-2022·2022-07-27
Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1258-2022·2022-07-27
FDA Recalls HYDROmorphone Injection Syringes Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 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. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1265-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, 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. Extension, West Columbia, SC 29172, NDC: 69374-979-50
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-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-1251-2022·2022-07-27
Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 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: 69374-925-10
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-1248-2022·2022-07-27
Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.
Product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled 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:
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1253-2022·2022-07-27
Glycopyrrolate Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, 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: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1252-2022·2022-07-27
Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Fentanyl Citrate Injection nationwide due to lack of assurance of sterility. Approximately 9,410 bags distributed to healthcare facilities are affected.
Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1273-2022·2022-07-27
Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1272-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.
Product
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 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: 69374-902-05
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