Impax Recalls Fenofibrate Capsules Due to Labeling Errors
Impax Laboratories recalls 28,001 bottles of Fenofibrate Capsules 134 mg due to incorrect or missing lot and expiration dates on the label.
Use caution until it’s fixed
Labeling: Incorrect or Missing Lot and/or Exp. Date
Contact the company
What happened, in plain English
Impax Laboratories, Inc. is recalling Fenofibrate Capsules (Micronized) 134 mg because the labeling contains incorrect or missing lot numbers and/or expiration dates. The affected product consists of 28,001 HDPE bottles distributed nationwide. This recall was initiated on March 17, 2016. Read more at govinfonow.com/recall/43107-impax-recalls-fenofibrate-capsules-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/43107-impax-recalls-fenofibrate-capsules-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0820-2016
Cite this page
“Impax Recalls Fenofibrate Capsules Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43107-impax-recalls-fenofibrate-capsules-due-to-labeling-errors. Based on FDA recall #D-0820-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0820-2016%22&limit=1).
Why it’s dangerous
The primary hazard is that the label does not accurately display the lot number or expiration date. This makes it difficult for patients and pharmacists to verify the age of the medication or track its manufacturing batch, which could lead to using expired product or confusion during a potential future safety alert.
Who’s affected
Consumers who purchased the specific lots of Fenofibrate Capsules 134 mg from pharmacies or retailers across the United States are affected. Patients relying on these specific bottles for their medication regimen are most at risk of confusion regarding product validity.
How to tell if you have this one
Check your bottle for the NDC 0115-0522-02. Verify if the lot number matches one of the following: 10008624, 10008831, 10009339, 10009566, 10009627, 10010200, 20001419A, 20001426A, 20001732A, 20001790A, 20001791A, or 20001792A. The bottle contains 500 capsules and was distributed by Impax Generics in Hayward, CA.
- Brand
Impax Generics- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0820-2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02; 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 | 28,001 HDPE bottles (14,000,500 capsules) |
| D-0821-2016 | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02; Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18 | 42,239 HDPE bottles ( 21,119,500 capsules) |
What to do — step by step
Check Your Bottle
Compare the lot number on your Fenofibrate Capsules bottle against the list of recalled lots provided in the record.
Contact Your Pharmacist
If you have one of the affected lots, contact your pharmacy or healthcare provider to discuss how to proceed with the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are being recalled?
The recall involves 28,001 HDPE bottles, containing a total of 14,000,500 capsules.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0820-2016 (March 17, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0820-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.