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

Fenofibrate Capsules (Micronized) 134 mg recalled by Impax Laboratories

Impax Laboratories is recalling Fenofibrate Capsules (Micronized) 134 mg, distributed nationwide in the US. The recall was initiated on 17 Mar 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 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

Quantity recalled28,001 HDPE bottles (14,000,500 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-0820-2016
FDA event ID: 73551
Recalling firm: Impax Laboratories, Hayward, CA
Classification: Class III
Status: Terminated
Recall initiated: 17 Mar 2016
FDA classified: 14 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Cholesterol Medication

Timeline

17 Mar 2016	Recall initiated by company
14 Apr 2016	Classified by FDA	+28 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

Product as listed by the FDA

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

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 # 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

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 73551

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

More recalls from Impax Laboratories

All 5

Reported	Class	Recall	Company	Reason	Where
28 Dec 2016Drug	CLASS I	Lamotrigine Orally Disintegrating Tablets (ODT) recalled	Impax Laboratories	Packaging Defects	Nationwide
27 Apr 2016Drug	CLASS II	Dextroamphetamine Sulfate Tablets USP, 5 mg recalled	Impax Laboratories	Potency & Assay	Nationwide
27 Apr 2016Drug	CLASS II	Dextroamphetamine Sulfate Tablets USP, 10 mg recalled	Impax Laboratories	Potency & Assay	Nationwide
20 Apr 2016Drug	CLASS III	Fenofibrate Capsules (Micronized) 200 mg recalled by Impax Laboratories	Impax Laboratories	Other	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) recalled	Amerisource Health Services	Packaging Defects	Nationwide