Fenofibrate Capsule
FDA Recall NDC 27241-119
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fenofibrate (NDC 27241-119). A significant event, classified as Class II, was initiated on May 28, 2026 by Ajanta Pharma Usa Inc.. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
May 28, 2026
Jul 01, 2026
3648 bottles
Recall Profile & Regulatory Data
Event ID
99130
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ajanta Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
Batch or Lot Expiration Information
Lot# PA02216; Exp. 12/2029
Affected Packages Involved in this Recall
27241-118-04Product
27241-118-05Product
27241-119-04Product
27241-119-05Product
27241-120-04Product
27241-120-05Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
106 BOXES
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
Batch or Lot Expiration Information
Lot# PA03410
Affected Packages Involved in this Recall
27241-118-04Product
27241-118-05Product
27241-119-04Product
27241-119-05Product
27241-120-04Product
27241-120-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
