Hazard

Sterility Assurance Failure recalls

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

What the numbers show

Total: 55
Critical: 0
Severe: 14
Most recent: 2026-05-13

Of the 55 sterility assurance failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (25%) 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 sterility assurance 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.

1–25 of 55

HighFDA (Drugs)·D-0512-2026·2026-05-13
DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from perforations that may compromise sterility. The recall affects 37,215 bags distributed nationwide.
Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0486-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
Product
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1532-2025·2025-04-16
Omnicell IVX Station Reconstitution Transfer Sets Recall
Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.
Product
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0295-2025·2025-04-02
Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2024·2024-04-03
HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
Product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0417-2024·2024-04-03
Injectable Phenylephrine Recall Due to Sterility Assurance Failure
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
Product
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1117-2023·2023-09-06
Neonatal TPN Starter Bag Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1138-2023·2023-09-06
dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1130-2023·2023-09-06
Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
Product
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1020-2023·2023-08-09
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1011-2023·2023-08-09
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were 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-0980-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0430-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0687-2023·2023-05-31
Neonatal Parenteral Nutrition Starter Bags Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 258 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility following an FDA inspection. The product is distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0709-2023·2023-05-31
Injectable oxyTOCIN solution recalled nationwide after sterility assurance questioned
Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in 0.9% sodium chloride injectable solution nationwide after an FDA inspection raised questions about the products' sterility assurance.
Product
oxyTOCIN 20 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 72185-6043-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0729-2023·2023-05-31
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling epinephrine injection (4 mg/250 mL) following FDA inspection findings that the product's sterility cannot be assured.
Product
EPINEPHrine added to dextrose 5%, 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 71285-7018-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0739-2023·2023-05-31
Heparin sodium chloride injection recalled nationwide due to sterility assurance questions
Central Admixture Pharmacy Services is recalling 1,300 bags of heparin injection nationwide after an FDA inspection questioned the product's sterility assurance.
Product
heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0663-2023·2023-05-31
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.
Product
Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0750-2023·2023-05-31
FDA Recalls Compounded Injectable Solution Due to Sterility Failure
Central Admixture Pharmacy Services recalled 653 bags of compounded injectable solution nationwide following an FDA inspection that questioned the product's sterility. The solution is intended for sterile injection use.
Product
MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0726-2023·2023-05-31
FDA Recalls Heparin-Sodium Chloride Injection Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,055 bags of heparin injection nationwide due to sterility assurance concerns identified during FDA inspection. Healthcare providers and patients should discontinue use of affected lots.
Product
heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2023·2023-05-24
YelloPort Elite Optical Trocars Recalled for Sterility Assurance Failure
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
Product
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0575-2023·2023-05-24
ADMELOG Insulin Lispro Recalled for Malformed Seal Defect
Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.
Product
ADMELOG — ADMELOG (INSULIN LISPRO)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0624-2023·2023-05-24
Piperacillin and Tazobactam for Injection Recalled Due to Sterility Assurance Failure
Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.
Product
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0288-2023·2023-02-22
Dextrose 10% TPN Solution Recalled Due to Sterility Assurance Concerns
Sentara Infusion Services is recalling Dextrose 10% 720ML TPN injectable solutions nationwide due to lack of sterility assurance. Patients using this product should contact their healthcare provider.
Product
Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0192-2023·2023-02-01
Albuterol Inhalation Solution Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling nationwide Albuterol 0.083% inhalation solution in 3ML tubes due to insanitary manufacturing facility conditions that compromise sterility assurance.
Product
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0114-2023·2023-01-18
TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 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