CLASS III Drug recall · Reported 20 Apr 2016 · FDA Enforcement Report

Fenofibrate Capsules (Micronized) recalled

Amerisource Health Services is recalling Fenofibrate Capsules (Micronized), 200 mg Unit Dose Blister Packs per, distributed nationwide in the US. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #142548; Exp. 05/16 Lot #145036; Exp. 10/16 Lot #151170; Exp. 03/17 Lot #152978; Exp. 09/17 Lot #155080; Exp. 01/18.

Quantity recalled5,034 cartons (151,020 capsules)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0823-2016
FDA event ID: 73715
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class III
Status: Terminated
Recall initiated: 31 Mar 2016
FDA classified: 14 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Cholesterol Medication

Timeline

31 Mar 2016	Recall initiated by company
14 Apr 2016	Classified by FDA	+14 days
20 Apr 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date

Which lots are affected?

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.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 73715

This product is part of a recall event; the main page for the event is Fenofibrate Capsules (Micronized) Unit Dose Blister Packs recalled.

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016	CLASS III	Fenofibrate Capsules (Micronized) Unit Dose Blister Packs recalled	Amerisource Health Services	Packaging Defects	Nationwide

More recalls from Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Fenofibrate (micronized recalls

All 3

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016Drug	CLASS III	Fenofibrate Capsules (Micronized) 200 mg recalled by Impax Laboratories	Impax Laboratories	Other	Nationwide
20 Apr 2016Drug	CLASS III	Fenofibrate Capsules (Micronized) 134 mg recalled by Impax Laboratories	Impax Laboratories	Other	Nationwide