Hazard

Sterility Defect recalls

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

What the numbers show

Total: 119
Critical: 0
Severe: 36
Most recent: 2026-07-08

Of the 119 sterility defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 36 (30%) 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 defect 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 119

HighFDA (Drugs)·D-1035-2023·2023-08-09
Cardioplegia Solution Recalled Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lacking validation data for decontamination cycles, creating insufficient assurance of sterility in this injectable product.
Product
CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Defect in Ultrasound Gel
Medline Industries is recalling custom procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed nationwide and internationally from 2020 to 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1033-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services has recalled 80 bags of Cardioplegia Solution (NDC 72196-0210-1) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0993-2023·2023-08-09
Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/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: 72196-0416-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2195-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2159-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling probe cover kits used during diagnostic ultrasound procedures due to an inadequate barrier at the seams that may compromise sterile integrity.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0652-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Defect
Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Cardioplegia Solution due to lack of assurance of sterility following an FDA inspection. The product was distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0664-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0692-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 427 bags of Neonatal TPN Starter Bag due to FDA concerns about sterility assurance. An FDA inspection questioned whether the product met required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0741-2023·2023-05-31
Tromethamine Injectable Syringes Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 225 syringes of tromethamine 0.3 Molar nationwide due to lack of sterility assurance identified during an FDA inspection. No illnesses have been reported.
Product
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0605-2023·2023-05-24
Cefepime for Injection Vials Recalled Over Sterility Concerns
Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.
Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0585-2023·2023-05-24
Ampicillin for Injection Recalled Due to Lack of Sterility Assurance
Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.
Product
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0593-2023·2023-05-24
FDA Recalls Ampicillin and Sulbactam Injectable Over Sterility Defect
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
Product
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0623-2023·2023-05-24
Injectable Antibiotic Recalled Due to Sterility Assurance Defect
Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0592-2023·2023-05-24
Ampicillin-Sulbactam Injection Recalled Due to Sterility Concerns
FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2023·2023-03-22
BD Ultra-Fine II insulin syringes recalled for sterility defect
Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.
Product
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0346-2023·2023-03-01
FDA Recalls Sodium Chloride Injection Due to Incomplete Container Seals
B. Braun Medical's 0.9% Sodium Chloride Injection batches recalled due to risk of incomplete seals that could allow leakage, potentially compromising sterility. The recall affects 1,343,982 bags distributed nationwide.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1114-2023·2023-02-22
Surgical Breast Biopsy Kits Recalled Due to Non-Sterile Outer Wrapping
Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.
Product
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0279-2023·2023-02-22
Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance
Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.
Product
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2023·2023-02-22
Surgical Convenience Kits Recalled Due to Non-Sterile Outer Packaging
Medline and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent sterility, leaving only the contents inside the kit wrapping sterile.
Product
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0320-2023·2023-02-22
TPN parenteral nutrition bags recalled due to lack of sterility
Sentara Infusion Services is recalling 31 TPN bags due to lack of sterility assurance. The recalled bags with Beyond Use Dates December 24–31, 2022, were dispensed nationwide to patients.
Product
TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0200-2023·2023-02-01
Pharmacy Innovations Cyclosporine Eye Drops Recalled for Sterility Defect
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
Product
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0039-2023·2022-11-09
Mitomycin Injection Recalled Due to Lack of Sterility Assurance
Vital Care Compounder is recalling 185 syringes of Mitomycin Injection due to lack of sterility assurance discovered during FDA inspection. The product cannot guarantee sterility.
Product
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states