Packaging Defects recalls

5,486 recalls have been issued for packaging defects, from 2012 to 21 Sep 2026. 341 of them came in the last 12 months. 508 were classified Class I.

Total recalls5,486since 2012

Last 12 months341reported

Class I5089% of total

Ongoing1,047latest 21 Sep 2026

Recalls per month, last 24 months

click a bar for that month

29Oct '24 14 19 18Jan '25 10 24 18Apr 21 18 31Jul 22 39 48Oct 76 28 10Jan '26 35 22 12Apr 9 29 26Jul 29 4

Severity split

Class I 508 9%Class II 4,551 83%Class III 412 8%Other/pending 15

Why packaging defects is recalled

Packaging Defects5,486100%

Companies

Product types

Brands

By year

20261763%
20253536%
20242625%
20232064%
20222114%
20212635%
20202995%
20193226%
201855010%
20172945%

Ongoing packaging defects recalls

1,047 active

Reported	Class	Recall	Company	Reason	Where
21 Sep 2026Drug	ANNOUNCED	ICU Medical LLC 9% Sodium Chloride Injection recalledICU Medical LLC	Otsuka ICU Medical	Packaging Defects	TX
13 Sep 2026Drug	ANNOUNCED	Compounded Glutathione 200 mg/mL multidose vial recalledCentric Compounding	Centric Compounding	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material recalled	Henry Schein	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Structur 2 SC Temporary Resin Cartridge Refill 75Gm recalled	Henry Schein	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide

All packaging defects recalls, newest first

5,486 total

Reported	Class	Recall	Company	Reason	Where
21 Sep 2026Drug	ANNOUNCED	ICU Medical LLC 9% Sodium Chloride Injection recalledICU Medical LLC	Otsuka ICU Medical	Packaging Defects	TX
13 Sep 2026Drug	ANNOUNCED	Compounded Glutathione 200 mg/mL multidose vial recalledCentric Compounding	Centric Compounding	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material recalled	Henry Schein	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Structur 2 SC Temporary Resin Cartridge Refill 75Gm recalled	Henry Schein	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Esteem Body Soft Convex Urostomy recalled by ConvaTec	ConvaTec	Packaging Defects	Nationwide
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	Glidesheath Slender A-kit 6f .021gw recalled by Terumo Medical	Terumo Medical	Packaging Defects	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.