Potency & Assay recalls

4,587 recalls have been issued for potency & assay, from 2012 to 30 Sep 2026. 259 of them came in the last 12 months. 127 were classified Class I.

Total recalls4,587since 2012

Last 12 months259reported

Class I1273% of total

Ongoing947latest 30 Sep 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 0

Severity split

Class I 127 3%Class II 3,390 74%Class III 1,070 23%

Why potency & assay is recalled

Potency & Assay4,587100%

Companies

Product types

Brands

By year

20261984%
20252145%
20242335%
20233287%
20223047%
20212355%
20203317%
20193317%
201863114%
201746910%

Ongoing potency & assay recalls

947 active

Reported	Class	Recall	Company	Reason	Where
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

All potency & assay recalls, newest first

4,587 total

Reported	Class	Recall	Company	Reason	Where
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
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Drug	CLASS III	Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride	Ajanta Pharma USA	Potency & Assay	Nationwide
16 Sep 2026Drug	CLASS III	Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled	ImprimisRx NJ	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS III	Revcovi (elapegademase-lvlr) Injection, 2.4mg/ (1.6 mg/mL) recalledRevcovi	Chiesi USA	Potency & Assay	MO, TN
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled	Allies Group	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled	Allies Group	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled	Allies Group	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled	Allies Group	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS III	Trokendi XR, (topiramate) extended-release capsules, 50 mg recalled	Supernus Pharmaceuticals	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium	Accord Healthcare	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.