Amerisource Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
Amerisource Health Services is recalling 5,034 cartons of Fenofibrate Capsules (Micronized), 200 mg, due to incorrect or missing lot and expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA 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/labeling error.
Plain-English summary
Amerisource Health Services is voluntarily recalling 5,034 cartons of Fenofibrate Capsules (Micronized), 200 mg, 30-count Unit Dose Blister Packs. The recall is being conducted because the product has incorrect or missing lot and/or expiration dates.
The affected product is packaged and distributed by American Health Packaging in Columbus, Ohio. The recall covers five specific lots: #142548 (Exp. 05/16), #145036 (Exp. 10/16), #151170 (Exp. 03/17), #152978 (Exp. 09/17), and #155080 (Exp. 01/18). The product was distributed nationwide.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
- Manufacturer
- Amerisource Health Services
- 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 (6)
- Lot #142548
- Exp. 05/16 Lot #145036
- Exp. 10/16 Lot #151170
- Exp. 03/17 Lot #152978
- Exp. 09/17 Lot #155080
- Exp. 01/18.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Amerisource Health Services 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 · Amerisource Health Services
See all →- HighAmerisource Recalls Paroxetine Tablets Due to Foreign Object Presence
FDA (Drugs) · 2017-11-29
- LowAmerisource Recalls Enalapril Maleate Tablets Due to Stability Failures
FDA (Drugs) · 2017-11-22
- ModerateAmerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-03-22
- ModerateCyclosporine Capsules Recalled for Impurity Specification Failures
FDA (Drugs) · 2017-03-08
- ModerateAHP Nifedipine Capsules Recalled for Presence of Foreign Tablets
FDA (Drugs) · 2016-11-30
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02