Hazard

Sterility Assurance recalls

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

What the numbers show

Total: 663
Critical: 0
Severe: 261
Most recent: 2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) 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 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.

351–375 of 663

HighFDA (Drugs)·D-0632-2023·2023-05-24
PHENYLephrine HCl Injection Recalled for Lack of Sterility Assurance
Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.
Product
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0619-2023·2023-05-24
Injectable Ceftriaxone Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
Product
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0615-2023·2023-05-24
Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Product
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0617-2023·2023-05-24
Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Product
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0647-2023·2023-05-24
Vancomycin IV Injection Recalled for Lack of Sterility Assurance
Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.
Product
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0359-2023·2023-03-08
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2023·2023-02-22
Medline CABG surgical convenience kits recalled due to sterility issue
Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.
Product
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0295-2023·2023-02-22
Hydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.
Product
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0277-2023·2023-02-22
Caspofungin Injectable Medication Recalled for Sterility Assurance Issues
Sentara Infusion Services is recalling Caspofungin 50mg injectable bags dispensed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.
Product
CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0307-2023·2023-02-22
FDA recalls Milrinone injectable medication due to lack of sterility assurance
Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.
Product
Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2023·2023-02-22
Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.
Product
Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0221-2023·2023-02-01
Methotrexate Injectable Vials Recalled for Lack of Sterility Assurance
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0230-2023·2023-02-01
Injectable Drug Recalled Due to Sterility Assurance Concerns
An injectable phosphatidylcholine/deoxycholic acid product manufactured by Pharmacy Innovations is being recalled nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0218-2023·2023-02-01
Lidocaine-PF Injectable Vials Recalled for Sterility Assurance Deficiency
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
Product
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0224-2023·2023-02-01
FDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Product
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0198-2023·2023-02-01
Injectable Vitamin D3 Recalled Over Sterility Concerns at Manufacturing Facility
Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility assurance.
Product
Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0242-2023·2023-02-01
Injectable Vitamin D3 Products Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling injectable Vitamin D3 products nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
Product
VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0220-2023·2023-02-01
Injectable vitamin formulations recalled due to facility sterility concerns
Pharmacy Innovations is recalling three injectable vitamin formulations due to insanitary facility conditions identified during FDA inspection that may affect product sterility.
Product
METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2023·2023-01-18
Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
Product
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0102-2023·2023-01-18
Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.
Product
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2023·2023-01-18
Prostaglandin E1 Injection Vials Recalled for Sterility Issues
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider.
Product
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2023·2023-01-18
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2023·2022-12-21
Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing
Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2023·2022-12-14
Intravenous Sodium Chloride Injection Recall for Potential Bag Leakage
B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
3 states