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.

126–150 of 1417

HighFDA (Drugs)·D-1120-2023·2023-09-06
Neonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1137-2023·2023-09-06
Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1105-2023·2023-08-30
Compounded Semaglutide/Cyanocobalamin Vials Recalled for Sterility Concerns
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.
Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1062-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0996-2023·2023-08-09
Neonatal TPN solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1029-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 144 bags of Cardioplegia Solution nationwide because validation data for sterilization cycles is lacking.
Product
CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1026-2023·2023-08-09
IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Product
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1030-2023·2023-08-09
Cardioplegia Solution 122 mEq K Recalled for Sterility Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1013-2023·2023-08-09
Oxytocin IV bags recalled nationwide for insufficient sterility assurance
Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1023-2023·2023-08-09
Cardioplegia Solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1009-2023·2023-08-09
Neonatal TPN starter bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0997-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1041-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0979-2023·2023-08-09
Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.
Product
heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1024-2023·2023-08-09
Cardioplegia solution IV bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0992-2023·2023-08-09
Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1034-2023·2023-08-09
Cardioplegia IV Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services has recalled Cardioplegia Solution due to lacking sterility assurance and insufficient validation data for decontamination cycles. The recall affects 148 bags distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1008-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1067-2023·2023-08-09
Fentanyl-bupivacaine injection syringes recalled due to sterility assurance issue
Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.
Product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1078-2023·2023-08-09
Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1021-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0964-2023·2023-08-09
Phenylephrine IV bags recalled due to sterility validation gaps
Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.
Product
phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1047-2023·2023-08-09
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2023·2023-08-09
Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
Product
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0998-2023·2023-08-09
Neonatal TPN Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
Category
Drug
Distribution
Distributed nationwide