Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Glenmark Pharmaceuticals Inc., USA

NDC code

68462-580-01

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0314-2025

Other Fenofibrate recalls

See all

Class II · Moderate risk Ongoing May 28, 2026

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta…

Reason CGMP Deviations

Ajanta Pharma USA Inc NDC 27241-120-04 D-0611-2026

Class II · Moderate risk Terminated Mar 15, 2021

FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0407-2021

Class III · Low risk Terminated Sep 12, 2018

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854…

Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP…

Hetero Labs, Ltd. - Unit III NDC 31722-596-90 D-1211-2018

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0823-2016

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0822-2016