Hazard

Sterility Failure recalls

462 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 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.

26–50 of 462

HighFDA (Drugs)·D-0333-2026·2026-02-18
Acyclovir Sodium Injection Recalled for Sterility Assurance Failure
Fresenius Kabi Compounding is recalling one lot of acyclovir sodium 200 mg intravenous injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0335-2026·2026-02-18
Thiamine HCl Injectable Solution Recalled for Lack of Sterility Assurance
Fresenius Kabi Compounding is recalling thiamine HCl injection (500 mg) due to lack of sterility assurance. The product was distributed nationwide.
Product
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
Blood Transfusion Filter Recall Due to Unconfirmed Sterility
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters because they were released before completing required quality control testing. Sterility assurance cannot be confirmed.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
HighFDA (Drugs)·D-0258-2026·2026-01-21
Testosterone Injectable Pellets Recalled for Sterility Assurance Issues
TESTO-100 CIII testosterone pellets are being recalled due to potential microbial contamination. The manufacturer could not ensure sterility of the product. Patients in affected regions should contact their healthcare provider.
Product
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0114-2026·2025-11-05
FDA Recalls Semaglutide Injection Vials for Lack of Sterility Assurance
ProRx LLC is recalling 2,809 vials of semaglutide injection (NDC 84139-225-09) from lot Prorx04282025-3 due to lack of assurance of sterility. Affected vials were distributed to Texas and Utah.
Product
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-0147-2026·2025-10-22
Ethicon Endo-Surgery Recalls Unsterilized ECHELON LINEAR Surgical Cutter Devices
Ethicon Endo-Surgery is recalling 3 unsterilized ECHELON LINEAR surgical cutters distributed to the United Arab Emirates. Unsterilized devices pose infection risk in surgical use.
Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0081-2026·2025-10-15
Reconstitution XO Solution for Injection Recalled Due to Sterility Concerns
Reconstitution XO Solution for Injection is being recalled nationwide due to lack of assurance of sterility in the manufacturing process.
Product
Reconstitution XO 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 CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0085-2026·2025-10-15
BPC-157 Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling BPC-157 for Injection nationwide due to lack of assurance of sterility in the manufacturing process. The product may contain microbial contamination, posing a risk to patients receiving injections.
Product
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0046-2026·2025-10-15
Bacteriostatic Water for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling all lots of Bacteriostatic Water for Injection nationwide due to lack of assurance of sterility, a serious concern for any injectable product.
Product
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2026·2025-10-15
GenoGenix Low Solubility Peptide Reconstitution Solution Lacks Sterility Assurance
GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection due to lack of assurance of sterility. The drug was distributed nationwide.
Product
Low Solubility Peptide 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 CELIA Health.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0053-2026·2025-10-15
GenoGenix Glutathione Injection Recalled Over Sterility Concerns
GenoGenix is recalling all lots of Glutathione Preserved for Injection nationwide due to lack of assurance of sterility. Non-sterile injectable products could expose patients to serious infections.
Product
Glutathione Preserved 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-0093-2026·2025-10-15
Retatrutide for Injection recalled for sterility assurance failure
GenoGenix LLC is recalling Retatrutide for Injection 60mg vials due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0079-2026·2025-10-15
Proline for Injection recalled for lack of sterility assurance
GenoGenix LLC is recalling all lots of Proline for Injection due to lack of assurance of sterility. Patients should contact their healthcare provider to discuss treatment options.
Product
Proline 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-0049-2026·2025-10-15
Calcium Chloride for Injection Recalled Due to Sterility Concerns
GenoGenix LLC is recalling all lots of Calcium Chloride for Injection nationwide due to lack of sterility assurance. Patients should discontinue use and contact their healthcare provider.
Product
Calcium Chloride 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-0048-2026·2025-10-15
Biotin for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling Biotin for Injection nationwide due to lack of assurance of sterility. The injectable product does not meet required sterility standards.
Product
Biotin 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-0080-2026·2025-10-15
FDA Recalls pH Buffered Reconstitution Solution for Sterility Assurance Failure
GenoGenix LLC is recalling pH Buffered Reconstitution Solution for Injection nationwide due to lack of assurance of sterility. All lots within expiration dates are affected.
Product
pH Buffered 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 Medical Health Institute (MHI), 10mL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2593-2025·2025-10-08
Medline sterile convenience kits recalled for lacking sterilization
Medline Industries recalls 88 Extremity Pack convenience kits that were labeled as sterile but did not undergo sterilization. The affected units were distributed to healthcare facilities in Florida, Maryland, New Jersey, and Tennessee.
Product
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2344-2025·2025-08-27
OtoLase Surgical Laser Starter Kit Recalled for Potential Sterilization Failure
Lumenis recalls OtoLase Starter Kit surgical lasers due to potential sterilization failures. Units may be unsterilized despite sterile labeling, creating infection risk.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2220-2025·2025-08-06
Celsior Cold Storage Solution recalled for potential sterility assurance failure
INSTITUT GEORGES LOPEZ has recalled 1,532 units of Celsior Cold Storage Solution, a sterile solution used to preserve hearts for transplantation, due to potential microbiological contamination from manufacturing defects. The affected lots were distributed in France.
Product
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0499-2025·2025-07-09
Bupivacaine with epinephrine sterile injection recalled for sterility manufacturing concerns
Tailstorm Health is recalling bupivacaine HCL with epinephrine sterile injections due to FDA-identified concerns with the sterile manufacturing process that could affect product sterility.
Product
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1960-2025·2025-07-02
Extended Tip Applicator 8CM Recalled for Endotoxin and Sterility Defects
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices (212 units) due to endotoxin contamination and lack of sterility assurance. The FDA Class I recall affects devices distributed in the US and internationally.
Product
Extended Tip Applicator 8CM, Box of 1.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1958-2025·2025-07-02
Extended Tip Applicator recalled for endotoxin and sterility issues
Integra LifeSciences recalls Extended Tip Applicators due to potentially out-of-specification endotoxin levels and lack of sterility assurance, affecting 6,216 units distributed nationwide and internationally.
Product
Extended Tip Applicator, 8CM, Box of 5.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1959-2025·2025-07-02
Extended Tip Applicator Recalled for Potential Sterility and Endotoxin Issues
Integra LifeSciences has recalled approximately 2,524 Extended Tip Applicators due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The devices were distributed nationwide in the US and internationally.
Product
Extended Tip Applicator, 15 CM, Box of 5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0486-2025·2025-07-02
Tirzepatide and Cyanocobalamin Injectable Products Recalled for Sterility Concerns
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin injectable products due to lack of assurance of sterility. Lot C03125A (242 syringes) distributed nationwide should not be used.
Product
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0494-2025·2025-07-02
Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Assurance Issues
Apotex Corp. is recalling 87,840 bottles of Ketorolac Tromethamine Ophthalmic Solution due to lack of sterility assurance. The prescription eye drop was distributed nationwide with batch TZ1236 expiring 11/30/2025.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide