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
Central Admixture Pharmacy Services, Inc.
Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA...
Injectable Drugs·3,165 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Servi...
Drugs·140 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, In...
Drugs·5,304 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 1810...
Injectable Drugs·3,326 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 65...
Drugs·11,338 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Phar...
Drugs·325 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, I...
Drugs·5,207 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy ...
Drugs·52 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18...
Drugs·225 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., S...
Drugs·3,865 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx onl...
Drugs·182 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valle...
Drugs·12,888 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Ce...
Drugs·328 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh V...
Drugs·79 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd.,...
Drugs·1,332 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Service...
Drugs·3,055 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Sno...
Drugs·690 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 65...
Drugs·3,040 affected·Apr 28, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc...
Drugs·13,953 affected·Apr 28, 2023
High RiskFDA
Akorn, Inc.
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 6003...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 ...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured ...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distr...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for rec...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 6...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, St...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Man...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Lumiradx
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566...
Medical Devices·1,003 affected·Apr 25, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Surgical Devices·1,054 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·17 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·40 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Surgical Devices·156 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·2 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Surgical Devices·175 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Surgical Devices·524 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Surgical Devices·436 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Surgical Devices·27 affected·Apr 22, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) ...
Medical Devices·342 affected·Apr 21, 2023
High RiskFDA
Sun Pharmaceutical Industries Ltd.
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only,...
Injectable Drugs·24,194 affected·Apr 19, 2023
High RiskFDA
Seatex Llc
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 1259...
Topical Drugs·2,880 affected·Apr 19, 2023
High RiskFDA
Deroyal Industries Inc
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.0...
Surgical Devices·23 affected·Apr 17, 2023