Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations
Is Fenofibrate recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Fenofibrate (11 total). Check the affected lots below.
Most common reason: Labeling / mix-up (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fenofibrate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fenofibrate recalls in 2026
1 initiated in 2026, 11 in total — newest first
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Fenofibrate Tablets
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk
Fenoglide (fenofibrate)
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Class II · Moderate risk
Fenofibrate
Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.
Class II · Moderate risk
Fenofibrate
Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug: FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD49448_4, EXP: 5/17/2014.
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