Amerisource Health Fenofibrate Recall: Labeling Errors
Amerisource Health Services recalls 228 cartons of 134 mg Fenofibrate capsules due to incorrect or missing lot and expiration dates on labels.
Use caution until it’s fixed
Labeling: Incorrect or Missing Lot and/or Exp Date
Contact the company
What happened, in plain English
Amerisource Health Services is recalling 228 cartons (4,560 capsules) of Fenofibrate Capsules (Micronized), 134 mg. The recall was issued because the labeling contains incorrect or missing lot numbers and/or expiration dates. This affects unit dose blister packs distributed nationwide. Read more at govinfonow.com/recall/43019-amerisource-health-fenofibrate-recall-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/43019-amerisource-health-fenofibrate-recall-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0822-2016
Cite this page
“Amerisource Health Fenofibrate Recall: Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43019-amerisource-health-fenofibrate-recall-labeling-errors. Based on FDA recall #D-0822-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0822-2016%22&limit=1).
Why it’s dangerous
Incorrect or missing lot and expiration dates on pharmaceutical labeling can lead to patients taking medication past its expiration date or being unable to verify the specific batch. This uncertainty may compromise the efficacy of the drug or prevent proper tracking in case of other quality issues.
Who’s affected
Patients who have been prescribed Fenofibrate Capsules (Micronized), 134 mg, specifically those who received unit dose blister packs from the affected lots. Individuals using these medications for cholesterol management are at risk of confusion regarding product validity.
How to tell if you have this one
Check for Fenofibrate Capsules (Micronized), 134 mg, packaged in 20-count unit dose blister packs per carton. Look for NDC numbers 68084-835-32 (carton) and 68084-835-33 (individual dose). Affected lots are #144332C (Exp. 04/16) and #155224 (Exp. 05/17).
- Brand
Amerisource Health Services- 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-0822-2016 | Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.; Lot #144332C; Exp. 04/16 Lot #155224; Exp. 05/17 | 228 cartons ( 4,560 capsules) |
| D-0823-2016 | 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.; 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. | 5,034 cartons (151,020 capsules) |
What to do — step by step
Check Your Medication Label
Verify if your Fenofibrate capsules match the affected lot numbers (#144332C or #155224) and expiration dates (04/16 or 05/17).
Contact Your Pharmacist
Speak with your pharmacist to determine if you have the recalled product and to discuss replacement options.
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 9 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.
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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-0822-2016 (March 31, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0822-2016 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.