Potency & Assay recalls

4,603 recalls have been issued for potency & assay, from 2012 to 21 Oct 2026. 254 of them came in the last 12 months. 127 were classified Class I.

Total recalls4,603since 2012

Last 12 months254reported

Class I1273% of total

Ongoing963latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

18Nov '24 30 13 17Feb 14 17 11May 16 21 12Aug 26 27 23Nov 17 7 2Feb 17 33 8May 17 54 19Aug 41 16

Severity split

Class I 127 3%Class II 3,402 74%Class III 1,073 23%Other/pending 1

Why potency & assay is recalled

Potency & Assay4,603100%

Companies

Product types

Brands

Levothyroxine Sodium591%
Daytrana321%
Atorvastatin Calcium160%
Tirosint150%
Levoxyl140%
Losartan Potassium120%
Amlodipine Besylate And Atorvastatin Calcium110%
Losartan Potassium And Hydrochlorothiazide110%

By year

20262145%
20252145%
20242335%
20233287%
20223047%
20212355%
20203317%
20193317%
201863114%
201746910%

Ongoing potency & assay recalls

963 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled	Microgenics	Potency & Assay	Nationwide
21 Oct 2026Device	CLASS II	Power F2 Powered Fastening System, Power F2 recalled by Ferno-Washington	Ferno-Washington	Potency & Assay	Nationwide
21 Oct 2026Drug	CLASS II	Hydrocortisone Sodium Succinate for Injection recalledHydrocortisone Sodium Succinate	Zydus Pharmaceuticals	Potency & Assay	Nationwide
21 Oct 2026Drug	ANNOUNCED	No Brand Name Compounded veterinary medications recalledNo Brand Name	Wedgewood Pharmacy	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS II	Tris/Tromethamine, USP, GMP, API Grade recalled by BioSpectra	BioSpectra	Potency & Assay	CA

All potency & assay recalls, newest first

4,603 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled	Microgenics	Potency & Assay	Nationwide
21 Oct 2026Device	CLASS II	Power F2 Powered Fastening System, Power F2 recalled by Ferno-Washington	Ferno-Washington	Potency & Assay	Nationwide
21 Oct 2026Drug	CLASS II	Hydrocortisone Sodium Succinate for Injection recalledHydrocortisone Sodium Succinate	Zydus Pharmaceuticals	Potency & Assay	Nationwide
21 Oct 2026Drug	ANNOUNCED	No Brand Name Compounded veterinary medications recalledNo Brand Name	Wedgewood Pharmacy	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS II	Tris/Tromethamine, USP, GMP, API Grade recalled by BioSpectra	BioSpectra	Potency & Assay	CA
14 Oct 2026Drug	CLASS III	Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS II	Fosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin Tromethamine	Cipla USA	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	NovaSeq 6000Dx including Dragen Server recalled by Illumina	Illumina	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Serum/Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Drug	CLASS II	Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine	Ajanta Pharma USA	Potency & Assay	Nationwide
7 Oct 2026Drug	CLASS II	Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride	Apotex	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
30 Sep 2026Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Chlorthalidone Tablets, USP, 25 mg recalled by Inventia HealthcareChlorthalidone	Inventia Healthcare	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Lidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaine	SUN Pharma /Taro	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS I	Thyroid Tablets, USP, 1/2 Grain (30 mg) recalledThyroid	Vitruvias Therapeutics	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
23 Sep 2026Drug	CLASS II	Fluphenazine HCl Elixir, USP, 15 mg per, Delivers recalled	Safecor Health	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	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.