Hazard

Sterility Assurance recalls

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

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.

26–50 of 309

HighFDA (Drugs)·D-0415-2026·2026-04-08
Sterile Eye Drops Recalled for Lack of Sterility Assurance
K.C. Pharmaceuticals is recalling 74,016 bottles of sterile eye drops sold under Rugby and Walgreens brands due to lack of assurance of sterility.
Product
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0410-2026·2026-04-08
Eye drops recall due to lack of sterility assurance
K.C. Pharmaceuticals is recalling Quality Choice Moisturizing Relief Eye Drops and related brand variants nationwide due to lack of sterility assurance. Approximately 303,216 bottles may be affected.
Product
QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS — QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2026·2026-04-01
Octreotide Acetate Injectable Suspension Recalled for Sterility Assurance Deficiency
Teva Pharmaceuticals is recalling Octreotide Acetate injectable suspension (30 mg) nationwide due to quality system deficiencies at the contract manufacturer that compromised sterility assurance.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0394-2026·2026-03-11
Tirzepatide 10mg Injectable Vials Recalled for Sterility Assurance Issues
New Life Pharma LLC is recalling 23 vials of Tirzepatide 10mg injectable due to lack of assurance of sterility. The affected batch (Lot 240709) was distributed in Ohio.
Product
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1406-2026·2026-02-25
Medline Surgical Drape Pack Recall Due to Sterilization Equipment Calibration Issues
Medline is recalling surgical drape packs due to sterilization equipment calibration issues that could compromise sterility levels. No illnesses have been reported.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2026·2026-02-25
Medline Surgical Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling surgical convenience kits used in orthopedic procedures due to sterilization equipment calibration issues that could compromise sterility assurance. The recall affects approximately 117,907 units distributed nationwide.
Product
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0337-2026·2026-02-18
Vancomycin injectable solution recalled due to sterility assurance issues
Fresenius Kabi is recalling vancomycin HCl injections distributed nationwide due to inability to assure product sterility. Two specific lots are affected.
Product
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0143-2026·2025-11-05
Injectable Sodium Chloride Solution Recalled Due to Sterility Assurance Concerns
Otsuka ICU Medical is recalling 509,360 units of sodium chloride 0.9% injection bags nationwide due to potential flexible container leaks that could compromise sterility. The recall affects lot 1029921 (expiration February 28, 2027).
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0028-2026·2025-10-22
FASENRA (Benralizumab) Injectable Drug Recall Due to Sterility
AstraZeneca is recalling FASENRA (benralizumab) pre-filled syringes due to lack of assurance of sterility. Patients who received injections from the recalled lot should contact their healthcare provider.
Product
FASENRA — FASENRA (BENRALIZUMAB)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0074-2026·2025-10-15
Injectable Exosome Solution Recalled for Lack of Sterility Assurance
GenoGenix has recalled Elite Stack MSC Exosome Reconstitution Solution due to inability to assure sterility of all lots. The injectable product was distributed nationwide and should not be administered pending further guidance.
Product
Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billio
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0089-2026·2025-10-15
Epithalon injection recalled due to unverified sterility assurance
GenoGenix LLC is recalling Epithalon for Injection, 20mg (Lot GG053025-002) due to lack of assurance of sterility. Distribution nationwide.
Product
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0050-2026·2025-10-15
GAC for Injection Recalled Due to Sterility Assurance Failure
GenoGenix LLC is recalling all lots of GAC for Injection due to lack of assurance of sterility. Patients should contact their healthcare provider regarding their medication.
Product
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0067-2026·2025-10-15
Injectable drug Tri-Immune recalled over sterility assurance issues
GenoGenix LLC is recalling all lots of Tri-Immune for Injection due to lack of assurance of sterility. The injectable medication is being recalled nationwide.
Product
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0003-2026·2025-10-15
Bevacizumab Intravitreal Injections Recalled for Lack of Sterility Assurance
RC Outsourcing is recalling Bevacizumab intravitreal injections due to lack of assurance of sterility. The recall affects 2,669 syringes distributed nationwide.
Product
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0072-2026·2025-10-15
CoQ10 for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling all strengths of CoQ10 for Injection nationwide. The manufacturer cannot assure the product meets sterility requirements required for injectable medications.
Product
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0040-2026·2025-10-15
Ascorbic Acid for Injection Recalled for Lack of Sterility Assurance
GenoGenix is recalling all lots of Ascorbic Acid (Vitamin C) for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0047-2026·2025-10-15
B-Complex for Injection Recalled Due to Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of B-Complex for Injection due to lack of assurance that the products meet sterility standards. The recall affects products distributed nationwide.
Product
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0069-2026·2025-10-15
Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues
GenoGenix LLC is recalling all lots of Vitamin D3 for Injection due to lack of assurance of sterility. The affected injectables were distributed nationwide.
Product
Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0676-2025·2025-10-08
Eye Medication Recalled for Sterility Assurance and Sealing Issues
Apotex Corp. is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to improper bottle sealing that compromises sterility assurance. Patients should contact their provider for a replacement.
Product
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0646-2025·2025-09-24
Bevacizumab Injection Syringes Recalled for Sterility Assurance Concerns
Fagron Compounding Services is recalling 109,320 syringes of bevacizumab (Avastin) Injection due to lack of assurance of sterility. The product was distributed nationwide with multiple lot numbers and expiration dates through December 2025.
Product
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0653-2025·2025-09-24
Drug irrigation solution recalled due to sterility and port leakage risk
B. Braun Medical recalls Sodium Chloride irrigation solution due to potential fluid leakage from port misalignment that could compromise sterility.
Product
SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2581-2025·2025-09-24
Frontier Devices 16mm Distraction Pin Recall Due to Unvalidated Shelf Life
Folsom Metal Products is recalling 490 units of Frontier Devices 16mm Distraction Pins nationwide due to unvalidated shelf life labeling. The label claim has not been substantiated.
Product
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0591-2025·2025-08-27
Pfizer Recalls Sodium Bicarbonate Injection Due to Sterility Assurance Concerns
Pfizer is recalling 15,750 vials of Sodium Bicarbonate Injection (8.4%, 50mEq/50mL) distributed nationwide due to lack of assurance of sterility. Lot LH2671, expiring 11/30/2026, may not meet required sterility standards for injectable medications.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0503-2025·2025-07-09
Lidocaine HCL Sterile Injection Recalled Due to Sterility Assurance Concerns
Tailstorm Health is recalling LIDOcaine HCL Sterile Injection (20 mg/mL, 10mL vials) nationwide due to lack of assurance of sterility identified during FDA inspection. No illnesses have been reported.
Product
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0501-2025·2025-07-09
KETAmine Injection Recall Due to Sterility Manufacturing Concerns
Tailstorm Health INC is recalling KETAmine Hydrochloride Injection due to sterility assurance concerns identified during FDA inspection. The recall affects 14,725 vials distributed nationwide.
Product
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
Category
Drug
Distribution
Distributed nationwide