Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Drugs·1,475 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
Drugs·1,758 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
Drugs·3,871 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Drugs·100 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Drugs·1,015 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-61...
Drugs·4,599 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Drugs·715 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Drugs·22,478 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
Drugs·146 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Drugs·14,848 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Drugs·70,959 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Drugs·60,868 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Drugs·1,699 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 7955...
Drugs·1,631 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Drugs·133 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Drugs·1,464 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
Drugs·670 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Drugs·50,990 affected·Jan 26, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospe...
Medical Devices·49,367 affected·Jan 16, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINAT...
Medical Devices·55,276 affected·Jan 16, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medical Devices·8,773 affected·Jan 5, 2026
High RiskFDA
Medline Industries, Lp
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOU...
Medical Devices·104,608 affected·Jan 5, 2026
High RiskFDA
Avid Medical, Inc.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Medical Devices·1,500 affected·Jan 2, 2026
High RiskFDA
Alphatec Spine, Inc.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 Th...
Surgical Devices·15 affected·Jan 2, 2026
High RiskFDA
Wizcure Pharmaa Private Limited
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-II...
Ophthalmic Drugs·184,320 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, ...
Ophthalmic Drugs·50,400 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl...
Ophthalmic Drugs·5,760 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phas...
Topical Drugs·17,280 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt...
Ophthalmic Drugs·139,104 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa P...
Ophthalmic Drugs·11,520 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. ...
Ophthalmic Drugs·10,080 affected·Dec 31, 2025
High RiskFDA
Baxter Healthcare Corporation
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-00...
Drugs·125,496 affected·Dec 22, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Medical Devices·41,526 affected·Dec 15, 2025
High RiskFDA
Fagron Compounding Services
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Oph...
Injectable Drugs·2,980 affected·Nov 20, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lu...
Injectable Drugs·32,736 affected·Nov 13, 2025
High RiskFDA
Otsuka Icu Medical Llc
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Injectable Drugs·509,360 affected·Oct 27, 2025
High RiskFDA
Medline Industries, Lp
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medical Devices·11,291,800 affected·Oct 27, 2025
High RiskFDA
Medline Industries, Lp
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Medical Devices·6,989,900 affected·Oct 27, 2025
High RiskFDA
Medline Industries, Lp
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
Medical Devices·1,725,600 affected·Oct 27, 2025
High RiskFDA
Medline Industries, Lp
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS
Medical Devices·1,566,500 affected·Oct 27, 2025
High RiskFDA
Medline Industries, Lp
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
Medical Devices·182,526 affected·Oct 27, 2025
High RiskFDA
Bristol-myers Squibb Company
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squ...
Injectable Drugs·12,778 affected·Oct 21, 2025
RecallFDA
Imprimis Njof, Llc
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bo...
Ophthalmic Drugs·67,091 affected·Oct 20, 2025
High RiskFDA
Prorx Llc
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, ...
Injectable Drugs·8,400 affected·Oct 15, 2025
High RiskFDA
Prorx Llc
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton,...
Injectable Drugs·8,310 affected·Oct 15, 2025
High RiskFDA
Prorx Llc
Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, P...
Injectable Drugs·2,649 affected·Oct 15, 2025
High RiskFDA
Prorx Llc
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton,...
Injectable Drugs·11,119 affected·Oct 15, 2025
High RiskFDA
Prorx Llc
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA...
Injectable Drugs·2,761 affected·Oct 15, 2025