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
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Centr...
Injectable Drugs·516 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy S...
Injectable Drugs·80 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Phar...
Injectable Drugs·356 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture...
Injectable Drugs·84 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue...
Injectable Drugs·4,570 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 8504...
Drugs·499,304 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...
Drugs·6,468 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue,...
Injectable Drugs·6,782 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx onl...
Injectable Drugs·68 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Centr...
Injectable Drugs·188 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Ser...
Injectable Drugs·192 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6...
Drugs·77,554 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd...
Injectable Drugs·5,588 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Ph...
Injectable Drugs·130,250 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Cent...
Injectable Drugs·12 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Ma...
Injectable Drugs·10,480 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, P...
Injectable Drugs·751 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, P...
Injectable Drugs·1,937 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Cen...
Injectable Drugs·296 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu...
Injectable Drugs·4,824 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix,...
Injectable Drugs·6,784 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Centr...
Injectable Drugs·80 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Servic...
Injectable Drugs·48 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture ...
Injectable Drugs·148 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 4...
Injectable Drugs·15,304 affected·Jul 14, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy ...
Injectable Drugs·56 affected·Jul 14, 2023
High RiskFDA
Peter Lazic Gmbh
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
Medical Devices·170 affected·Jul 14, 2023
High RiskFDA
New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 m...
Drugs·102 affected·Jul 13, 2023
High RiskFDA
Sagent Pharmaceuticals
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in...
Injectable Drugs·65,710 affected·Jul 11, 2023
High RiskFDA
Sagent Pharmaceuticals
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-6...
Injectable Drugs·65,710 affected·Jul 11, 2023
High RiskFDA
Sagent Pharmaceuticals
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and...
Injectable Drugs·760 affected·Jul 11, 2023
High RiskFDA
Tenn South Distillery Llc Dba Big Machine Distillery
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machi...
Topical Drugs·540 affected·Jul 10, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, R...
Drugs·132,299 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 uni...
Injectable Drugs·137,304 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton...
Drugs·92,148 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, R...
Drugs·125,598 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case,...
Drugs·2,088 affected·Jul 7, 2023
High RiskFDA
Karl Storz Endoscopy
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Medical Devices·218 affected·Jul 7, 2023
High RiskFDA
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5...
Injectable Drugs·79,880 affected·Jul 5, 2023
High RiskFDA
Medtronic Neurosurgery
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Surgical Devices·44 affected·Jun 28, 2023
High RiskFDA
Microtek Medical Inc.
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/cas...
Medical Devices·9,293 affected·Jun 23, 2023
High RiskFDA
Scican Ltd.
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by mea...
Medical Devices·19 affected·Jun 22, 2023
High RiskFDA
Megadyne Medical Products, Inc.
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suct...
Medical Devices·241,457 affected·Jun 15, 2023
High RiskFDA
K.c. Pharmaceuticals, Inc
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG h...
Ophthalmic Drugs·341,568 affected·Jun 13, 2023
High RiskFDA
Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Medical Devices·106 affected·Jun 13, 2023
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOn...
Medical Devices·3 affected·Jun 8, 2023
High RiskFDA
Osteomed, Llc
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Medical Devices·0 affected·May 31, 2023
High RiskFDA
Osteomed, Llc
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Medical Devices·0 affected·May 31, 2023