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
Pharm D Solutions, Llc
Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·66 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Injectable Drugs·716 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pha...
Injectable Drugs·669 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Sol...
Injectable Drugs·4 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·1 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·371 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·24 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·25 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·6 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm...
Injectable Drugs·4 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·100 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Injectable Drugs·50 affected·May 23, 2019
High RiskFDA
Pharm D Solutions, Llc
Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Drugs·26 affected·May 23, 2019
High RiskFDA
Anewmed Corporation
Various products which were contract sterilized.
Medical Devices·1,749 affected·May 23, 2019
CriticalFDA
Heritage Pharmaceuticals, Inc.
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, Ind...
Injectable Drugs·14,960 affected·May 21, 2019
CriticalFDA
Heritage Pharmaceuticals, Inc.
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, In...
Injectable Drugs·55,480 affected·May 21, 2019
CriticalFDA
Edwards Lifesciences, Llc
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-ao...
Medical Devices·6,552 affected·May 14, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, ND...
Drugs·730 affected·May 3, 2019
High RiskFDA
Xtant Medical Inc
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONT...
Surgical Devices·26 affected·May 3, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP01...
Medical Devices·125,292 affected·May 2, 2019
High RiskFDA
Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (V...
Medical Devices·12,833 affected·May 2, 2019
High RiskFDA
Cook Inc.
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Medical Devices·97 affected·May 2, 2019
High RiskFDA
Abbott Vascular
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Medical Devices·0 affected·May 1, 2019
High RiskFDA
Sagent Pharmaceuticals Inc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, ...
Injectable Drugs·75,825 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle Item code: 8881200029
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Advanced Pharma Inc.
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded D...
Injectable Drugs·560 affected·Apr 26, 2019
CriticalFDA
Terumo Medical Corporation
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835...
Surgical Devices·2,228 affected·Apr 26, 2019
High RiskFDA
Centurion Medical Products Corporation
STERILE CAP CHANGE KIT DYNDC1946B
Medical Devices·181,965 affected·Apr 24, 2019
High RiskFDA
Inopak Ltd
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Inopak Ltd
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate)...
Drugs·17,850 affected·Apr 22, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 22701 Material: 701050790
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
Medical Devices·0 affected·Apr 18, 2019