Fenofibrate recalls

Fenofibrate products have been recalled 4 times, most recently on 1 Jul 2026. The recalling company is usually Hetero Labs, Ltd. - Unit III. The most common reason is manufacturing (cgmp) deviations.

Total recalls4since 2018

Last 12 months1reported

Class I00% of total

Ongoing2latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why fenofibrate is recalled

Manufacturing (CGMP) Deviations375%
Other Reasons125%

Companies

Product types

Cholesterol Medication4100%

By year

2026125%
2025125%
2021125%
2018125%

Ongoing fenofibrate recalls

2 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate	Ajanta Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Fenofibrate Capsules 67 mg recalled by Glenmark PharmaceuticalsFenofibrate	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide

All fenofibrate recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate	Ajanta Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Fenofibrate Capsules 67 mg recalled by Glenmark PharmaceuticalsFenofibrate	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Fenofibrate Capsules, Ups 67mg recalled by Cardinal HealthFenofibrate	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
3 Oct 2018Drug	CLASS III	Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate	Hetero Labs, Ltd. - Unit III	Other	IN, LA

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.