Hazard

Sterility Failure recalls

462 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 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.

251–275 of 462

HighFDA (Drugs)·D-0661-2023·2023-05-31
FDA Recalls Cardioplegia Solution for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling cardioplegia solution due to sterility assurance concerns identified in an FDA inspection. The recall affects 269 bags distributed nationwide.
Product
Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0730-2023·2023-05-31
Prescription Injectable Epinephrine and Dextrose Solution Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services has recalled nationwide 2,542 bags of prescription-only injectable epinephrine and dextrose solution due to lack of sterility assurance following an FDA inspection.
Product
EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0708-2023·2023-05-31
FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0713-2023·2023-05-31
Injectable Diltiazem Recalled Over Sterility Assurance Concerns from FDA Inspection
Central Admixture Pharmacy Services is recalling 3,040 bags of prescription diltiazem injection after FDA inspection raised concerns about product sterility. The medication was distributed nationwide.
Product
dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0681-2023·2023-05-31
Cardiac Perfusion Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
Product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0676-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0745-2023·2023-05-31
Drug Recall: NORepinephrine Injectable Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling NORepinephrine injectable solution nationwide after an FDA inspection questioned the product's sterility assurance. The recall affects 4,994 bags.
Product
NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0751-2023·2023-05-31
Injection Solution Recalled Due to Sterility Assurance Concerns
Nationwide recall of Sodium Phosphates Injection due to lack of sterility assurance after FDA inspection. Patients receiving this medication should consult their healthcare provider.
Product
Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0763-2023·2023-05-31
Nafcillin Injectable Medication Recalled for Sterility Assurance Failure
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP 2 gram vials nationwide due to lack of assurance of sterility in the manufacturing process. This FDA Class II recall affects multiple lots distributed across the United States.
Product
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0710-2023·2023-05-31
Oxytocin Injectable Solution Recalled for Sterility Assurance Questions
Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.
Product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0701-2023·2023-05-31
FDA Recalls Epinephrine Injection Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,338 bags of epinephrine injectable solution nationwide. The FDA raised concerns about sterility assurance during an inspection.
Product
EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0754-2023·2023-05-31
FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0748-2023·2023-05-31
Vasopressin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
Product
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0656-2023·2023-05-31
FDA Recalls Microplegia Solution for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
Product
Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0678-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to failed sterility assurance after FDA inspection. 363 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0638-2023·2023-05-24
Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance
Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.
Product
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0627-2023·2023-05-24
Piperacillin and Tazobactam Injection Recalled for Lack of Sterility Assurance
Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.
Product
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2023·2023-05-24
Surgical Optical Trocars Recalled Due to Sterility Assurance Failure
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.
Product
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0628-2023·2023-05-24
Antibiotic Injection Vials Recalled for Sterility Assurance Failure
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0631-2023·2023-05-24
Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure
Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0616-2023·2023-05-24
Ceftriaxone Injectable Antibiotic Recalled Nationwide for Sterility Assurance Deficiency
Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.
Product
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0637-2023·2023-05-24
FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure
Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.
Product
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0597-2023·2023-05-24
Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Failure
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0646-2023·2023-05-24
FDA Recalls Fentanyl and Ropivacaine Injectable for Lack of Sterility Assurance
Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.
Product
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0633-2023·2023-05-24
Succinylcholine Injection recalled for lack of sterility assurance
Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.
Product
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
Category
Drug
Distribution
0 states