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
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·196,442 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company...
Ophthalmic Drugs·18,171 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compan...
Ophthalmic Drugs·8,747 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·8,000 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·8,810 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company,...
Ophthalmic Drugs·8,868 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Compan...
Topical Drugs·16,500 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indian...
Topical Drugs·282,564 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·83,898 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Topical Drugs·8,819 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company,...
Ophthalmic Drugs·196,111 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Comp...
Ophthalmic Drugs·8,873 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, ...
Topical Drugs·180,315 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc...
Ophthalmic Drugs·5,509 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company...
Ophthalmic Drugs·293,400 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
LAVH, REF BBLV21C
Medical Devices·18 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack SAH, REF SAR530M
Medical Devices·96 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
Medical Devices·112 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Vasc. Open CVOR SJH, REF SJVO56B
Medical Devices·84 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
CVS PCSU SJH, REF SJCV48J
Medical Devices·36 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Pediatric Heart SJH, REF SJPH34K
Cardiac Devices·72 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Cath Cardiac Pack, REF IHCC03V
Cardiac Devices·1,260 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SSRO22D
Medical Devices·56 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Sub Q Recorder Pack, REF BPRC87A
Medical Devices·96 affected·Sep 1, 2023
CriticalFDA
Dr. Berne's Whole Health Products
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@dr...
Drugs·0 affected·Aug 26, 2023
High RiskFDA
Sofie Co Dba Sofie
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only,...
Injectable Drugs·6 affected·Aug 22, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
Medical Devices·79,500 affected·Aug 22, 2023
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Medical Devices·0 affected·Aug 22, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam steriliza...
Medical Devices·77,280 affected·Aug 22, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization pr...
Medical Devices·33,504 affected·Aug 22, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Aven...
Injectable Drugs·554 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 ...
Injectable Drugs·340 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixtu...
Injectable Drugs·92 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 Sou...
Injectable Drugs·577 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy S...
Injectable Drugs·200 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 Sou...
Injectable Drugs·340 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy ...
Injectable Drugs·40 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx onl...
Injectable Drugs·136 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central ...
Drugs·84 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx...
Injectable Drugs·132 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd...
Injectable Drugs·2,643 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 Sou...
Injectable Drugs·297 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 Sou...
Injectable Drugs·586 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 4...
Injectable Drugs·235 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Cent...
Injectable Drugs·108 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, In...
Injectable Drugs·16 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2...
Drugs·477 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Servi...
Drugs·184 affected·Aug 17, 2023