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.

201–225 of 447

HighFDA (Drugs)·D-0680-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide Due to Unverified Sterility
Central Admixture Pharmacy Services is recalling 79 bags of Cardioplegia Solution nationwide because an FDA inspection found that the sterility of the product could not be assured.
Product
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0711-2023·2023-05-31
Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.
Product
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0733-2023·2023-05-31
Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.
Product
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0694-2023·2023-05-31
Neonatal TPN Starter Bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 128 bags of Neonatal TPN Starter Bag after FDA inspection raised concerns about sterility assurance. The product is used for intravenous nutritional support in newborns.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0423-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0655-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.
Product
Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0762-2023·2023-05-31
Nafcillin for Injection recalled nationwide for lack of sterility assurance
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP due to lack of assurance of sterility. Approximately 2.2 million vials distributed nationwide are affected.
Product
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0666-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Product
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0722-2023·2023-05-31
Vancomycin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 9,037 bags of vancomycin injectable due to FDA concerns about sterility assurance. Products distributed nationwide may not meet required sterility standards.
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0716-2023·2023-05-31
IV Potassium Phosphate Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.
Product
potassium phosphate 15 mmole 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 71285-6060-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0707-2023·2023-05-31
Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0688-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0416-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0689-2023·2023-05-31
Neonatal TPN Starter Bag Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0418-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0683-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0764-2023·2023-05-31
Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.
Product
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0589-2023·2023-05-24
Ampicillin Injection Recalled for Lack of Sterility Assurance
Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.
Product
Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0645-2023·2023-05-24
FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
Product
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0588-2023·2023-05-24
Ampicillin for Injection Recalled for Lack of Sterility Assurance
Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.
Product
Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0586-2023·2023-05-24
Ampicillin for Injection Recalled Due to Sterility Assurance Concerns
Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.
Product
Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0630-2023·2023-05-24
Piperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue
Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.
Product
Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0580-2023·2023-05-24
Ampicillin for Injection Recall Due to Sterility Assurance Concerns
Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.
Product
Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0640-2023·2023-05-24
Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Product
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0641-2023·2023-05-24
Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns
Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.
Product
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0582-2023·2023-05-24
Ampicillin Injection Vials Recalled for Sterility Assurance Failure
Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0601-2023·2023-05-24
Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect
The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0614-2023·2023-05-24
Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.
Product
Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
Category
Drug
Distribution
Distributed nationwide