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
Us Compounding Inc
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barco...
Drugs·1,686 affected·Jan 29, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ...
Ophthalmic Drugs·69,840 affected·Jan 24, 2019
High RiskFDA
Djo, Llc
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Medical Devices·9 affected·Jan 17, 2019
High RiskFDA
Advanced Pharma Inc.
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syr...
Injectable Drugs·160 affected·Jan 15, 2019
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGu...
Injectable Drugs·146 affected·Jan 10, 2019
High RiskFDA
Convatec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary ...
Surgical Devices·5,744,525 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duo...
Medical Devices·1,231,155 affected·Jan 9, 2019
High RiskFDA
Conformis, Inc.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Medical Devices·2 affected·Jan 4, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India ...
Injectable Drugs·5,060 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Methocarbamol liquid 100mg/ml, RX, glass vial
Drugs·300 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Lidocaine gel 2%, RX, plastic dropper
Topical Drugs·125 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Drugs·20 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Glutathione liquid, 200mg/ml, Rx
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Supplements·310 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Lidocaine gel 1%, RX, plastic dropper
Topical Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
HCG liquid, 1000u/ml, RX, glass vial, various
Drugs·30 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Testosteron Cypionate liquid 200mg/ml, RX, glass vial
Drugs·200 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Drugs·830 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Vitamin B12 liquid 1000mcg/ml, RX, glass vial
Supplements·150 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Glutathione liquid, 100mg/ml
Drugs·60 affected·Jan 2, 2019
High RiskFDA
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthca...
Drugs·29,370 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye o...
Injectable Drugs·50 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Epinephrine liquid 1:1000, RX, glass vial
Drugs·50 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 1%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Hiers Enterprises, Llc Dba Northwest Compounding Pharmacy
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Drugs·0 affected·Jan 2, 2019
High RiskFDA
Cardinal Health 200, Llc
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointmen...
Medical Devices·10,400 affected·Dec 27, 2018
High RiskFDA
Boston Scientific Corporation
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Medical Implants·18 affected·Dec 26, 2018
RecallFDA
Akorn Inc
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distribute...
Ophthalmic Drugs·30,794 affected·Dec 20, 2018
High RiskFDA
Lgm Pharma Llc
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian...
Drugs·205 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Medical Devices·2,502 affected·Dec 18, 2018
High RiskFDA
Promise Pharmacy, Llc
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34...
Ophthalmic Drugs·75 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·2 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·2 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·7 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·94 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, R...
Supplements·204 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·37 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·927 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Prom...
Ophthalmic Drugs·900 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·1 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·11 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg...
Injectable Drugs·64 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy C...
Injectable Drugs·3 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hw...
Ophthalmic Drugs·167 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·266 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise...
Ophthalmic Drugs·250 affected·Dec 17, 2018