Fenofibrate recalls

The FDA has published 6 recalls involving Fenofibrate since 2014. The latest was reported on 1 Jul 2026. Most were for manufacturing (cgmp) deviations. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2014

Last 12 months1reported

Class I00% of total

Ongoing2latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why fenofibrate is recalled

Companies

By year

2026117%
2025117%
2021117%
2018117%
2014233%

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., USA	Manufacturing (CGMP) Deviations	Nationwide

All fenofibrate recalls, newest first

6 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., USA	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
29 Jan 2014Drug	CLASS II	Fenofibrate, Tablet, 54 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Fenofibrate, Tablet, 54 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Fenofibrate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.