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
Pine Pharmaceuticals, Llc
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Rive...
Injectable Drugs·26 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 3...
Ophthalmic Drugs·662 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Injectable Drugs·2,862 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tona...
Drugs·201 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmac...
Injectable Drugs·136 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuti...
Ophthalmic Drugs·2,181 affected·Oct 2, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Gastrointestinal Videoscope
Medical Devices·1,687 affected·Oct 2, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Surgical Devices·2,460 affected·Sep 29, 2023
High RiskFDA
B. Braun Medical, Inc.
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microsph...
Medical Devices·760 affected·Sep 26, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, ND...
Drugs·50 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San...
Drugs·71 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., ...
Drugs·1,190 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, S...
Drugs·1,459 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only,...
Drugs·190 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro...
Drugs·1,762 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Di...
Drugs·3,081 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Di...
Drugs·3,384 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dun...
Drugs·598 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro...
Drugs·1,767 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, ND...
Drugs·174 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe,...
Drugs·895 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 9212...
Drugs·4,775 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 7128...
Drugs·3,590 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 ...
Drugs·4,550 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, ...
Drugs·419 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa...
Drugs·962 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA ...
Drugs·240 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 ...
Drugs·1,190 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, R...
Drugs·60 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dun...
Drugs·688 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dun...
Drugs·403 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dun...
Drugs·1,792 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., ...
Drugs·19,510 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook R...
Drugs·398 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite...
Drugs·476 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-60...
Drugs·1,992 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Du...
Drugs·2,664 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego...
Drugs·1,590 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Di...
Drugs·1,389 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 79...
Drugs·5,378 affected·Sep 21, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook R...
Drugs·274 affected·Sep 21, 2023
RecallFDA
Imprimis Njof, Llc
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle...
Ophthalmic Drugs·6,228 affected·Sep 20, 2023
RecallFDA
Tolmar, Inc.
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935...
Injectable Drugs·2,990 affected·Sep 12, 2023
High RiskFDA
Be Pharmaceuticals Ag
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-1...
Injectable Drugs·41,148 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Ophthalmic Drugs·8,747 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceutica...
Ophthalmic Drugs·30,490 affected·Sep 1, 2023