Hazard

Lack Of Sterility Assurance recalls

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

What the numbers show

Total: 44
Critical: 0
Severe: 16
Most recent: 2025-07-02

Of the 44 lack of sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (36%) are Severe.

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 assurance 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.

1–25 of 44

SevereFDA (Drugs)·D-0478-2025·2025-07-02
NAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.
Product
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2025·2025-07-02
Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
Product
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2024·2024-04-03
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2024·2024-04-03
PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0022-2024·2023-10-11
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0015-2024·2023-10-11
Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect
Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses nationwide.
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-1157-2023·2023-09-27
Sterile Eye Drops Recalled for Lack of Sterility Assurance TRP Natural Eyes
TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.
Product
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1126-2023·2023-09-06
Phenylephrine IV Bags Recalled for Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.
Product
PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0962-2023·2023-08-09
FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.
Product
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1046-2023·2023-08-09
FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0667-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile assurance.
Product
Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0649-2023·2023-05-31
Cardioplegia Solution recalled due to lack of sterility assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.
Product
Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0714-2023·2023-05-31
FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.
Product
norepinephrine 4 mg added to dextrose 5% 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 71285-6056-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0698-2023·2023-05-31
FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns
Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility after an inspection.
Product
Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0607-2023·2023-05-24
Cefepime for Injection recalled nationwide for lack of sterility assurance
Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.
Product
Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0602-2023·2023-05-24
Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Deficiency
Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.
Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0626-2023·2023-05-24
Piperacillin and Tazobactam Injectable: Lack of Sterility Assurance Recall
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
Product
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0278-2023·2023-02-22
Cefazolin Antibiotic Injections Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Cefazolin antibiotic injections due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed nationwide.
Product
CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0302-2023·2023-02-22
Levothyroxine Injectable Syringes Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling levothyroxine injectable syringes dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if they received this product.
Product
LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0311-2023·2023-02-22
Nalbuphine Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
Product
NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2023·2023-01-18
Prostaglandin Injectable Recalled Nationwide Due to Sterility Assurance Concerns
Northern VA Compounders PLLC is recalling a compounded Prostaglandin (E1) Injection due to lack of sterility assurance. Patients should consult their healthcare provider immediately.
Product
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0055-2023·2022-11-09
Sterile Talc Powder Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling sterile talc powder vials after FDA inspection found the manufacturing process cannot guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0030-2023·2022-11-09
Ceftazidime Intravitreal Solution Recalled for Sterility Assurance Failure
Vital Care Compounder is recalling Ceftazidime intravitreal injection solutions due to manufacturing conditions that cannot guarantee product sterility. Affected lots were distributed to patients in Alabama, Louisiana, Mississippi, and Tennessee.
Product
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-1256-2022·2022-07-27
HYDROmorphone HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling HYDROmorphone HCl Injection syringes nationwide due to lack of assurance of sterility. The recall affects 12,900 syringes across two manufacturing lots.
Product
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 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: 69374-529-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1227-2022·2022-07-20
Compounded Sermorelin/Glycine Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
Product
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide