Potency & Assay recalls

4,143 recalls have been issued for potency & assay, from 2012 to 9 Sep 2026. 230 of them came in the last 12 months. 99 were classified Class I.

Total recalls4,143since 2012

Last 12 months230reported

Class I992% of total

Ongoing825latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

12Oct '24 18 29 15Jan '25 18 11 14Apr 10 18 19Jul 11 20 24Oct 22 12 8Jan '26 2 17 40Apr 7 13 50Jul 11 20

Severity split

Class I 99 2%Class II 3,037 73%Class III 1,007 24%

Why potency & assay is recalled

Potency & Assay4,143100%

Companies

Product types

Brands

By year

20261684%
20251945%
20242025%
20232877%
20222937%
20212275%
20203508%
20193087%
201856414%
20172576%

Ongoing potency & assay recalls

825 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	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 recalledTrokendi Xr	Supernus Pharmaceuticals	Potency & Assay	Nationwide

All potency & assay recalls, newest first

4,143 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	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 recalledTrokendi Xr	Supernus Pharmaceuticals	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 5mg recalled by ApotexPaxil	Apotex	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg 1 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.