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.

326–350 of 1691

HighFDA (Drugs)·D-0043-2023·2022-11-09
Pharmacy Compounded Injection Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable medication because manufacturing did not ensure sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-1779-2022·2022-10-05
SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles
SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.
Product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Category
Medical Device
Distribution
10 states
HighFDA (Drugs)·D-1528-2022·2022-09-21
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.
Product
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1707-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1518-2022·2022-09-21
Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance
Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.
Product
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1534-2022·2022-09-21
FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure
Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.
Product
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1521-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.
Product
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1532-2022·2022-09-21
TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.
Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1531-2022·2022-09-21
Injectable drug recalled due to lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.
Product
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1514-2022·2022-09-21
Injectable Anesthetic Solution Recalled for Lack of Sterility Assurance
Pine Pharmaceuticals is recalling Bupivacaine and Lidocaine injectable solutions for eye anesthesia due to lack of assurance of sterility. The product was distributed to direct accounts in four states.
Product
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Park
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-1515-2022·2022-09-21
L-Carnitine Injectable Recalled Due to Sterility Assurance Failure
Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.
Product
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1496-2022·2022-09-14
Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1267-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2022·2022-07-27
Nonsterile Components in Medical Convenience Kits Recalled
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.
Product
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-1280-2022·2022-07-27
Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.
Product
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 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: 69374-906-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1268-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 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: 69374-979-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1264-2022·2022-07-27
Lidocaine HCl injection syringes recalled due to sterility assurance failure
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 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: 69374-985-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1281-2022·2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 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: 69374-919-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1276-2022·2022-07-27
Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 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: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1260-2022·2022-07-27
Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 syringes distributed nationwide.
Product
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 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: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1259-2022·2022-07-27
Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.
Product
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 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: 69374-982-55
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1274-2022·2022-07-27
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 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: 69374-955-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1275-2022·2022-07-27
Phenylephrine HCl injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 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: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1207-2022·2022-07-20
Gonadorelin Drug Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1195-2022·2022-07-20
Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.
Product
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide