Hazard

Infection recalls

2,547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,547
Critical: 31
Severe: 1,678
Most recent: 2026-09-09

Of the 2,547 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,678 (66%) 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 infection 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.

1176–1200 of 2547

SevereFDA (Drugs)·D-0015-2017·2016-10-19
Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns
Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about sterility.
Product
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0018-2017·2016-10-19
Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns
Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.
Product
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0014-2017·2016-10-19
FDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns
Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about sterility.
Product
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0016-2017·2016-10-19
Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns
Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.
Product
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0002-2017·2016-10-12
Methylcobalamin Injection Recalled Due to Sterility Assurance Issues
The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection in Oklahoma because the medication was sterilized with a recalled filter.
Product
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1546-2016·2016-10-05
Vital Care Compounder Recalls Olopatadine Eye Drops for Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Olopatadine 0.8% Ophthalmic Solution due to a lack of assurance of sterility.
Product
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1541-2016·2016-10-05
FDA Recalls Autologous Serum Tears Due to Sterility Assurance Concerns
The FDA is recalling Autologous Serum Tears from Vital Care Compounder due to a lack of assurance of sterility. The product was distributed in Mississippi.
Product
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1535-2016·2016-10-05
FDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine and Prostaglandin vials due to a lack of assurance of sterility.
Product
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1547-2016·2016-10-05
FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/Atrop 150/7.5 injection vials due to a lack of assurance of sterility.
Product
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1539-2016·2016-10-05
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. is recalling Morphine Sulfate 15mg/ml Injection due to a lack of assurance of sterility. The product was distributed in Mississippi.
Product
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1511-2016·2016-09-28
The Apothecary Recalls Sterile Injection Medications Due to Sterility Assurance Concerns
The Apothecary is recalling unexpired lots of sterile injection medications due to unsubstantiated validation of beyond-use dating, which raises concerns about sterility.
Product
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1508-2016·2016-09-28
The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Concerns
The Apothecary is recalling Calcium Gluconate IV bags because the pharmacy could not verify that the products remained sterile for their labeled duration.
Product
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1510-2016·2016-09-28
The Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
The Apothecary is recalling unexpired lots of Papaverine, Phentolamine, Calcium Gluconate, and Prostaglandin medications due to unsubstantiated validation of beyond use dating and lack of sterility assurance.
Product
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1509-2016·2016-09-28
Calcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns
The Apothecary is recalling Calcium Gluconate syringes due to unsubstantiated validation of beyond use dating and lack of sterility assurance.
Product
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1512-2016·2016-09-28
The Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns
The Apothecary is recalling specific lots of Prostaglandin and other medications due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating.
Product
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2831-2016·2016-09-21
C.R. Bard Recalls Option-vm Urinary Catheters Due to Sterility Concerns
C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.
Product
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Category
Medical Device
Distribution
15 states
SevereFDA (Drugs)·D-1498-2016·2016-09-14
Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns
Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2733-2016·2016-09-14
Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise
Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.
Product
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2672-2016·2016-09-07
Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling
Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because labeling failed to indicate they are single-use only, posing a cross-contamination risk.
Product
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2567-2016·2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.
Product
Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2575-2016·2016-08-24
Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.
Product
Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction v
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2462-2016·2016-08-24
Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Product
Drill Stop Dental implants
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2250-2016·2016-07-27
Centurion Convenience Kits Recalled Due to Defective Medtronic Light Glove
Centurion is recalling 483 convenience kits containing Medtronic light gloves with potential splits or holes that could transfer microorganisms to patients.
Product
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
Category
Medical Device
Distribution
6 states
SevereFDA (Drugs)·D-1176-2016·2016-07-20
Medaus Recalls Calcium Sodium EDTA Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Calcium Sodium EDTA 300mg/mL vials because the agency cannot assure the product's sterility.
Product
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1227-2016·2016-07-20
Medaus Recalls Molybdenum Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.
Product
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide