Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,691
Critical: 12
Severe: 931
Most recent: 2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 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.

1051–1075 of 1691

HighFDA (Drugs)·D-0264-2017·2017-01-11
Tri-Coast Pharmacy Recalls Infuvite IV Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV compounded between May and November 2016 because the agency cannot assure the products are sterile.
Product
Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0186-2017·2016-12-21
Cantrell Drug Company Recalls Calcium Chloride Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 73 bags of Calcium Chloride in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0195-2017·2016-12-21
Cantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 935 vials of Hydromorphone HCl 50 mg/50 mL single-dose syringes due to a lack of assurance of sterility.
Product
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0191-2017·2016-12-21
Cantrell Drug Recalls Glycopyrrolate Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Glycopyrrolate injection because the firm cannot assure the sterility of the product.
Product
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0203-2017·2016-12-21
Cantrell Drug Recalls Ropivacaine HCl Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 87 bags of Ropivacaine HCl 0.25% due to a lack of assurance of sterility. The product is intended for epidural use only.
Product
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0204-2017·2016-12-21
Cantrell Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride 200 mg/10 mL injection syringes because the firm cannot ensure the products are sterile.
Product
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0196-2017·2016-12-21
Cantrell Drug Recalls Hydromorphone Injection Vials Due to Sterility Concerns
Cantrell Drug Company is recalling 93 vials of Hydromorphone HCl injection solution nationwide due to a lack of assurance of sterility.
Product
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0202-2017·2016-12-21
Cantrell Drug Recalls Rocuronium Bromide Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 5,067 syringes of Rocuronium Bromide 50 mg/5 mL injection solution nationwide due to a lack of assurance of sterility.
Product
Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0189-2017·2016-12-21
Cantrell Drug Company Recalls Fentanyl Citrate Bags Due to Sterility Concerns
Cantrell Drug Company is recalling Fentanyl Citrate bags due to a lack of assurance of sterility. The recall affects 2,545 bags distributed nationwide.
Product
Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0193-2017·2016-12-21
Cantrell Drug Recalls Heparin Sodium Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 150 bags of Heparin Sodium 5,000 USP Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0185-2017·2016-12-21
Cantrell Drug Company Recalls Phenylephrine HCl Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 30,796 syringes of Phenylephrine HCl 1 mg/10 mL due to a lack of assurance of sterility. The recall covers products distributed nationwide.
Product
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0180-2017·2016-12-14
North American Rescue Recalls Amphibious Trauma Kits Due to Sterility Concerns
North American Rescue is recalling Amphibious Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.
Product
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2017·2016-12-07
Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.
Product
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA0
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0691-2017·2016-12-07
B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing
B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.
Product
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns
Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays
Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0125-2017·2016-11-09
PharMEDium Recalls Succinylcholine Chloride Vials Due to Sterility Concerns
PharMEDium Services is recalling specific vials of Succinylcholine Chloride because a portion of the batch was compounded outside of validated process media, raising sterility concerns.
Product
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2017·2016-10-19
Leiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns
Leiter's Compounding is recalling placebo ophthalmic suspensions because they were produced using recalled filters, raising concerns about sterility.
Product
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0074-2017·2016-10-19
Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues
Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.
Product
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0075-2017·2016-10-19
Banyan Medical Pyramidal Tip Trocar Recalled for Sterility Concerns
Banyan Medical is recalling 5 x 55mm Pyramidal Tip Trocars due to a potential lack of assurance of sterility. The recall affects 64 boxes distributed in Indiana and Tennessee.
Product
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Category
Medical Device
Distribution
2 states
SevereFDA (Drugs)·D-0003-2017·2016-10-12
Apothecary Shoppe Recalls Phenotolamine and Prostaglandin Vials Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL vials because they were sterilized with a recalled filter, raising concerns about sterility assurance.
Product
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1542-2016·2016-10-05
FDA Recalls Pre-Op Pledget Ophthalmic Drops Due to Sterility Concerns
Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln ophthalmic drops due to a lack of assurance of sterility. The recall affects 6 vials distributed in Mississippi.
Product
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1548-2016·2016-10-05
Vital Care Compounder Recalls Hyaluronidase Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 23 vials of Hyaluronidase due to a lack of assurance of sterility. The affected lot was distributed in Mississippi.
Product
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1549-2016·2016-10-05
FDA Recalls Vital Care Compounder DMSO and Lidocaine Vials for Sterility Concerns
Pharmacy Plus, Inc. is recalling specific lots of DMSO 50% with Lidocaine 0.5% vials due to a lack of assurance of sterility.
Product
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2848-2016·2016-09-28
Smith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures
Smith & Nephew is recalling Renasys Sterile Transparent Film and related dressing kits because sterility seal integrity failures may compromise the sterile barrier.
Product
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and bo
Category
Medical Device
Distribution
Distributed nationwide