Hazard

Sterility Assurance recalls

309 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 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.

51–75 of 309

HighFDA (Drugs)·D-0478-2025·2025-07-02
NAD+ Injection Solution Recalled for Sterility Assurance Failure
Thrive Health Solutions is recalling NAD+ pre-filled syringes nationwide due to lack of assurance of sterility. The affected product may not be sterile and could pose infection risks to users.
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
HighFDA (Drugs)·D-0485-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling 216 syringes of Tirzepatide/Cyanocobalamin Injectable (lot C03065F) because the manufacturer cannot assure the products are sterile. Patients should contact their healthcare provider.
Product
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/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-0474-2025·2025-07-02
Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling Methylcobalamin Injectable (10mg/mL, lot H228307) due to lack of assurance of sterility. This product was distributed nationwide and may not meet required sterility standards for injectable medications.
Product
Methylcobalamin Injectable, 10mg/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-0476-2025·2025-07-02
LL Bioboost injectable supplement recalled for lack of sterility
Thrive Health Solutions is recalling LL Bioboost Injectable pre-filled syringes because the manufacturer cannot assure the product was manufactured under sterile conditions. Consumers should stop using the product and consult their healthcare provider.
Product
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2025·2025-06-18
Ophthalmic knives recalled due to sterility assurance concerns
Tecfen Medical is recalling 92 units of 2.2mm Slit Knife, Angled (Model QKN2261) due to sterility assurance concerns. The devices were distributed worldwide.
Product
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2025·2025-05-14
Lubricant Eye Drops Solution Recalled for Sterility and Manufacturing Defects
BRS Analytical Services recalled Lubricant Eye Drops Solution nationwide due to cGMP deviations and lack of sterility assurance. The product may carry contamination risk and should not be used.
Product
LUBRICANT EYE DROPS SOLUTION — LUBRICANT EYE DROPS SOLUTION (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0405-2025·2025-05-14
Eye Lubricant Gel Recalled for Manufacturing Control Failures
AvKARE is recalling carboxymethylcellulose sodium ophthalmic gel due to cGMP deviations and failure to assure sterility. Affected lots were distributed nationwide.
Product
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1524-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling 9,020 units of Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The affected devices were distributed worldwide and may pose an infection risk.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1522-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 4,000 units of Ballard Closed Suction Catheters Model 210 used in neonatal and pediatric care due to lack of sterility assurance. The recall affects devices distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0297-2025·2025-04-02
Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 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 (Devices)·Z-1406-2025·2025-03-26
Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0174-2025·2025-01-08
Injectable phenylephrine recalled due to defective tamper-evident seals nationwide
Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.
Product
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0173-2025·2025-01-08
Ketamine injection syringes recalled due to missing tamper-evident seals
Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.
Product
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0548-2024·2024-06-19
FDA Recalls Eye Suspension Medication for Lack of Sterility Assurance
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
Product
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1807-2024·2024-05-22
Medline Namic Fluid Delivery Set Recalled for Lack of Sterility Assurance
Medline Industries is recalling Namic Fluid Delivery Sets (lot 0000113381) because they lack sterility assurance, which could allow contamination during medical procedures.
Product
Namic FLUID DELIVERY SET, REF 91300040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0479-2024·2024-05-08
EYLEA injection recalled for sterility concerns and syringe breakage complaints
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
Product
EYLEA — EYLEA (AFLIBERCEPT)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0436-2024·2024-04-10
Injectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
SSM Health Care is recalling 140 vials of fentanyl citrate injection because the manufacturer did not perform required process validation to ensure sterility.
Product
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0395-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.
Product
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0415-2024·2024-04-03
Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1079-2024·2024-02-28
Surgical Kit with Saline Recalled Over Sterility Assurance Issue
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
Product
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Category
Medical Device
Distribution
3 states
HighFDA (Drugs)·D-0057-2024·2023-10-25
Cefuroxime Injectable Syringes Recalled for Lack of Sterility Assurance
Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.
Product
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0054-2024·2023-10-25
Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.
Product
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0017-2024·2023-10-11
Fentanyl and Bupivacaine Injectable Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0030-2024·2023-10-11
Hydromorphone Syringe Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.
Product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0005-2024·2023-10-11
Phenylephrine injectable drug recalled due to sterility assurance failure
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. 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