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
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76...
Ophthalmic Drugs·386,256 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Sing...
Ophthalmic Drugs·401,568 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by:...
Ophthalmic Drugs·45,408 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) b...
Drugs·9,216 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles,...
Drugs·253,080 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, ...
Topical Drugs·110,832 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by:...
Ophthalmic Drugs·56,520 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles...
Drugs·10,944 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio ...
Ophthalmic Drugs·14,784 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunt...
Ophthalmic Drugs·6,024 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) a...
Ophthalmic Drugs·137,784 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bot...
Ophthalmic Drugs·33,984 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168...
Topical Drugs·150,720 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-...
Ophthalmic Drugs·210,192 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017...
Drugs·23,208 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livo...
Ophthalmic Drugs·1,492,344 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite A...
Topical Drugs·7,776 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane,...
Topical Drugs·7,200 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed ...
Drugs·12,960 affected·Nov 13, 2023
CriticalFDA
Kilitch Healthcare India Limited
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter L...
Ophthalmic Drugs·7,296 affected·Nov 13, 2023
RecallFDA
Fagron Compounding Services
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical O...
Injectable Drugs·756 affected·Nov 10, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuti...
Injectable Drugs·5,948 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, N...
Injectable Drugs·2,458 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceutical...
Injectable Drugs·909 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·400 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ...
Injectable Drugs·324 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pha...
Injectable Drugs·1,259 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceutic...
Injectable Drugs·1,023 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Ph...
Injectable Drugs·10,017 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 R...
Injectable Drugs·5,079 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·548 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceu...
Injectable Drugs·500 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Wi...
Injectable Drugs·1,122 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow...
Drugs·1,425 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rai...
Injectable Drugs·9,624 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE...
Injectable Drugs·412 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Phar...
Injectable Drugs·2,427 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceutic...
Injectable Drugs·256 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Phar...
Injectable Drugs·3,671 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmac...
Injectable Drugs·399 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rai...
Injectable Drugs·1,508 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd...
Injectable Drugs·381 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL U...
Injectable Drugs·613 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA ...
Injectable Drugs·33,072 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL US...
Injectable Drugs·130 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only...
Injectable Drugs·5,734 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT ...
Injectable Drugs·368 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, ...
Injectable Drugs·5,392 affected·Nov 9, 2023