Sterility recalls

13,684 recalls have been issued for sterility, from 2012 to 30 Sep 2026. 602 of them came in the last 12 months. 1,270 were classified Class I.

Total recalls13,684since 2012

Last 12 months602reported

Class I1,2709% of total

Ongoing2,596latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

17Nov '24 9 88 15Feb 50 79 34May 29 60 7Aug 28 105 21Nov 12 4 59Feb 19 56 104May 67 70 32Aug 56 0

Severity split

Class I 1,270 9%Class II 12,379 90%Class III 35 0%

Why sterility is recalled

Sterility13,684100%

Companies

Customed6825%
King Bio4653%
The Compounding Pharmacy of America3833%
Medline Industries LP - Northfield3813%
Central Admixture Pharmacy Services3443%
Windstone Medical Packaging3112%
Stryker Endoscopy2302%
Resource Optimization & Innovation2242%

Product types

Brands

By year

20264673%
20255284%
20245514%
20239547%
20226525%
20216785%
20206645%
20191,86914%
20188666%
20171,1538%

Ongoing sterility recalls

2,596 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Major LubriFresh P.M. Nighttime Ointment recalled	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5%	Sterling Pharmaceutical Services	Sterility	Nationwide

All sterility recalls, newest first

13,684 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Major LubriFresh P.M. Nighttime Ointment recalled	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5%	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Lubricant Eye Drops-Cameron Pharmaceuticals recalled	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye recalled	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recalledGentle Eyes Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Blood Culture Collection Venipuncture Kit 20/Cs recalled	Medical Action Industries Inc. 306	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Haylard Continuous Nerve Block Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS I	Medline Convenience Kits: Port Access Kit Univ OF Ala recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Convenience kits Minor Pack DYNJ58421A Springhill Minor recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Medline Convenience Kits recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Convenience kits Anesthesia Pain PK League DYNJ67925A recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Convenience kits Myringotomy Pack-lf DYNJ59097A recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Haylard Basic Biopsy Tray kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Medline Convenience Kits recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Medline Convenience Kits: Open Heart Adult recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Medline Convenience Kits recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Medline Convenience Kits: Kit Anesthesia L&d A- Line Set recalled	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical	Avid Medical	Sterility	4 states
23 Sep 2026Device	CLASS II	Medline Convenience Kit: Open Heart A Pack recalled	Medline Industries	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.