Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,423
Critical: 3
Severe: 1,055
Most recent: 2026-10-14

Of the 1,423 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 1,055 (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 1423

HighFDA (Drugs)·D-1121-2023·2023-09-06
Neonatal TPN IV Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 92 bags of neonatal TPN IV bags (lot 36-262161) because of inadequate validation of manufacturing sanitization processes. The affected product was distributed nationwide.
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-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-1122-2023·2023-09-06
Neonatal TPN Nutrition Bags Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1107-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1140-2023·2023-09-06
DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1127-2023·2023-09-06
FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization
Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.
Product
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1109-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1124-2023·2023-09-06
Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
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-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-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-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-1052-2023·2023-08-09
FDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure
The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.
Product
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
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-1019-2023·2023-08-09
Cardioplegia Solution Recalled Due to Lacking Decontamination Validation Data
A cardioplegia solution is being recalled nationwide because the manufacturer lacks validation data for decontamination cycles, raising sterility assurance concerns. Affected lots: 36-254401 and 36-257070.
Product
CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1
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-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-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-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-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-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-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-0952-2023·2023-08-09
Glycopyrrolate Injectable for Anesthesia Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 770 syringes of glycopyrrolate injectable medication nationwide due to lack of validation data for sterilization processes. The product may not meet required sterility standards for safe anesthesia use.
Product
glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0985-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1006-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
Category
Drug
Distribution
Distributed nationwide