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
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 46...
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, P...
Injectable Drugs·76 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 6...
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Topical Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 6...
Injectable Drugs·28 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·5 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61...
Injectable Drugs·8 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PH...
Injectable Drugs·64 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peo...
Injectable Drugs·4 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peo...
Injectable Drugs·35 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Drugs·7 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 462...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·5 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·5 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 46...
Injectable Drugs·261 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peor...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4...
Injectable Drugs·7 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and ...
Injectable Drugs·21 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx ...
Injectable Drugs·49 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·6 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. Universi...
Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria,...
Injectable Drugs·10 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61...
Injectable Drugs·30 affected·Sep 3, 2015
High RiskFDA
Bausch & Lomb Inc Irb
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available i...
Medical Devices·99,260 affected·Sep 3, 2015
High RiskFDA
Summit Medical, Inc.
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation,...
Medical Devices·9 affected·Sep 3, 2015
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, De...
Injectable Drugs·139,104 affected·Sep 2, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE o...
Cardiac Devices·0 affected·Aug 31, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE ...
Cardiac Devices·355 affected·Aug 31, 2015
High RiskFDA
Eagle Pharmacy, Inc.
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin...
Injectable Drugs·104 affected·Aug 28, 2015
High RiskFDA
B. Braun Medical, Inc.
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Medical Devices·433 affected·Aug 27, 2015
High RiskFDA
Zimmer, Inc.
Zimmer Guide Wires for orthopedic procedures.
Medical Devices·112,568 affected·Aug 27, 2015
High RiskFDA
Edwards Lifesciences, Llc
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged...
Cardiac Devices·759 affected·Aug 26, 2015
High RiskFDA
Apotex Inc.
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg...
Ophthalmic Drugs·5,520 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Cardiac Devices·153 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Surgical Devices·84 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
Cardiac Devices·28 affected·Aug 25, 2015