Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
Impax Laboratories is recalling 28,001 bottles of Fenofibrate Capsules (Micronized) 134 mg because the bottles have incorrect or missing lot and expiration dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation and labeling defect rather than a physical hazard.
Plain-English summary
Impax Laboratories, Inc. is recalling 28,001 HDPE bottles of Fenofibrate Capsules (Micronized) 134 mg, 500-count, Rx Only. The product is distributed by Impax Generics in Hayward, CA, and carries the NDC 0115-0522-02. The recall covers a total of 14,000,500 capsules.
The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The affected lots include # 10008624, 10008831, 10009339, 10009566, 10009627, 10010200, 20001419A, 20001426A, 20001732A, 20001790A, 20001791A, and 20001792A, with expiration dates ranging from 10/16 to 05/18. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Manufacturer
- Impax Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot # 10008624
- 10008831
- Exp. 10/16 Lot # 10009339
- Exp. 02/17 Lot # 10009566
- 10009627
- Exp. 04/17 Lot # 10010200
- 20001419A
- 20001426A
- Exp. 10/17 Lot # 20001732A
- Exp. 04/18 Lot # 20001790A
- 20001791A
- 20001792A
- Exp. 05/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Impax Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Impax Laboratories, Inc.
See all →- SevereImpax Recalls Lamotrigine Tablets Due to Labeling Mixup
FDA (Drugs) · 2016-12-28
- SevereImpax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2016-04-27
- SevereImpax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2016-04-27
- LowImpax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
Similar recalls
- LowAmerisource Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20
- LowAmerisource Health Services Recalls Fenofibrate Capsules Due to Labeling Errors
FDA (Drugs) · 2016-04-20
- ModerateAidapak Recalls Fenofibrate Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
- LowMutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error
FDA (Drugs) · 2014-01-15
- SevereFDA Recalls Phenobarbital Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-29
- ModerateFDA Recalls Fenofibrate Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-29