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
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lak...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed b...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson an...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Medical Devices·200 affected·Mar 9, 2026
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical Devices·100 affected·Mar 9, 2026
High RiskFDA
Milestone S.r.l.
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Medical Devices·61,600 affected·Mar 9, 2026
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
Medical Devices·3,460 affected·Mar 9, 2026
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
Medical Devices·3,880 affected·Mar 9, 2026
High RiskFDA
Lsl Healthcare Inc.
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical Devices·2,200 affected·Mar 9, 2026
High RiskFDA
Payless Compounders, Llc
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Injectable Drugs·91 affected·Mar 6, 2026
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp.,...
Ophthalmic Drugs·107,136 affected·Mar 5, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED B...
Ophthalmic Drugs·589,848 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY ...
Ophthalmic Drugs·245,184 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed B...
Ophthalmic Drugs·378,144 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Dist...
Ophthalmic Drugs·1,023,096 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Dis...
Ophthalmic Drugs·315,144 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Steri...
Ophthalmic Drugs·303,216 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED B...
Ophthalmic Drugs·182,424 affected·Mar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LU...
Ophthalmic Drugs·74,016 affected·Mar 3, 2026
High RiskFDA
Wilson-cook Medical Inc.
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Medical Devices·713,702 affected·Mar 3, 2026
High RiskFDA
New Life Pharma Llc
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
Drugs·2 affected·Feb 26, 2026
High RiskFDA
New Life Pharma Llc
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Drugs·45 affected·Feb 26, 2026
High RiskFDA
New Life Pharma Llc
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Drugs·23 affected·Feb 26, 2026
High RiskFDA
New Life Pharma Llc
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Drugs·820 affected·Feb 26, 2026
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery...
Medical Devices·361 affected·Feb 19, 2026
High RiskFDA
Harbin Jixianglong Biotech Co., Ltd.
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g...
Drugs·0 affected·Feb 13, 2026
High RiskFDA
Harbin Jixianglong Biotech Co., Ltd.
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g,...
Drugs·0 affected·Feb 13, 2026
CriticalFDA
Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Medical Devices·368,264 affected·Feb 13, 2026
CriticalFDA
Erbe Usa Inc
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Surgical Devices·64,216 affected·Feb 12, 2026
High RiskFDA
Leo Pharma Inc
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) ...
Injectable Drugs·11,407 affected·Feb 10, 2026
High RiskFDA
Valley Springs Artesian Gold, Llc
Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC ...
Beverages·379,868 affected·Feb 6, 2026
High RiskFDA
International Life Sciences
Artelon FlexBand Dynamic Matrix Ref: 31057
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
International Life Sciences
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
International Life Sciences
Artelon FlexBand Plus Ref: 41054 & 41057
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
Fresenius Kabi Compounding, Llc
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021...
Injectable Drugs·10,548 affected·Feb 5, 2026
High RiskFDA
Fresenius Kabi Compounding, Llc
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA...
Injectable Drugs·1,410 affected·Feb 5, 2026
High RiskFDA
Fresenius Kabi Compounding, Llc
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, ...
Injectable Drugs·1,578 affected·Feb 5, 2026
High RiskFDA
Fresenius Kabi Compounding, Llc
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 0...
Injectable Drugs·0 affected·Feb 5, 2026
High RiskFDA
Fresenius Kabi Compounding, Llc
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile...
Injectable Drugs·1,057 affected·Feb 5, 2026
High RiskFDA
Becton Dickinson & Company
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Medical Devices·204,000 affected·Jan 27, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Drugs·153,498 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Drugs·194,336 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Drugs·89,074 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Drugs·2,442 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Drugs·62,581 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Drugs·24,099 affected·Jan 26, 2026
High RiskFDA
F.h. Investments, Inc. (dba Asteria Health)
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6...
Drugs·7,840 affected·Jan 26, 2026