Abbott Laboratories recalls

Abbott Laboratories has 153 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 19 Nov 2025. 67 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls153since 2012

Last 12 months1reported

Class I4127% of total

Ongoing67latest 19 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 5 0May 0 0 0Aug 0 0 1Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 41 27%Class II 96 63%Class III 16 10%

Why abbott laboratories is recalled

Product types

Brands

By year

202564%
202464%
202343%
20226341%
202164%
202064%
20193120%
201843%
201753%
201632%

Ongoing abbott laboratories recalls

67 active

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Alinity hq Analyzer recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide

All abbott laboratories recalls, newest first

153 total

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Alinity hq Analyzer recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
28 Aug 2024Device	CLASS II	Alinity hq Analyzer recalled by Abbott Laboratories	Abbott Laboratories	Other	Nationwide
10 Apr 2024Device	CLASS II	Architect Stat Myoglobin Reagent Kit, LN 2K43-25 and 2K43 recalled	Abbott Laboratories	Particulate Matter	Nationwide
17 Jan 2024Device	CLASS II	Architect c4000 Processing Module recalled by Abbott Laboratories	Abbott Laboratories	Foreign Material	48 states
17 Jan 2024Device	CLASS II	Alinity c Processing Module recalled by Abbott Laboratories	Abbott Laboratories	Foreign Material	48 states
17 Jan 2024Device	CLASS II	Alinity i Processing Module recalled by Abbott Laboratories	Abbott Laboratories	Foreign Material	48 states
3 Jan 2024Device	CLASS II	Alinity ci-series System Control Module recalled by Abbott Laboratories	Abbott Laboratories	Potency & Assay	46 states
27 Dec 2023Device	CLASS II	Abbott Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Foreign Material	38 states
15 Nov 2023Food	CLASS II	Similac Probiotic Tri-Blend recalled by Abbott LaboratoriesSimilac Probiotic	Abbott Laboratories	Packaging Defects	41 states
19 Apr 2023Food	CLASS II	Zone Perfect Fudge Graham bar bars recalled by Abbott LaboratoriesZone Perfect	Abbott Laboratories	Foreign Material	35 states
25 Jan 2023Device	CLASS III	Alinity Reaction Vessels recalled by Abbott Laboratories	Abbott Laboratories	Other	11 states
23 Nov 2022Food	CLASS II	Similac Stage 1 (Export Colombia) reclose able Packaged as: case recalledSimilac Stage	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Pedialyte Unflavored Electrolyte Solution 12- in a case recalledPedialyte Unflavored	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Pedialyte Unflavored (Export to Canada) case recalledPedialyte Unflavored	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac Stage 1 (Export Dominican Republic) reclose able recalledSimilac Stage	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac Special Care reclose able Packaged as recalledSimilac Special	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac Water - Sterilized (Export Canada) reclose able recalledSimilac	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac 360 Total Care Sensitive recalled by Abbott LaboratoriesSimilac	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac Total Comfort reclose able Packaged as: 12 - in a case recalledSimilac Total	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac 360 Total Care/Similac 360 Total Care Sensitive recalledSimilac	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac 360 Total Care Sensitive reclose able Packaged as recalledSimilac	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac Neosure reclose able Packaged as: case recalledSimilac Neosure	Abbott Laboratories	Mold	51 states
23 Nov 2022Food	CLASS II	Similac 360 Total Care reclose able Packaged as: carton case recalledSimilac	Abbott Laboratories	Mold	51 states
7 Sep 2022Device	CLASS II	Architect Stat Troponin-I Reagent Kit recalled by Abbott Laboratories	Abbott Laboratories	Other	Nationwide
31 Aug 2022Food	CLASS II	Abbott Jevity Complete, Balanced Nutrition recalledAbbott Jevity	Abbott Laboratories	Packaging Defects	7 states

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.