The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0821-2016·Announced 2016-04-20

Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

Impax Laboratories is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg because some bottles have incorrect or missing lot and expiration dates.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error (incorrect or missing lot/expiration dates) rather than a product defect or contamination.

Plain-English summary

Impax Laboratories, Inc. is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg, 500-count, Rx Only. The product is distributed by Impax Generics, Hayward, CA, under NDC 0115-0533-02. The recall involves a total of 21,119,500 capsules.

The recall was initiated because some bottles have incorrect or missing lot and/or expiration dates. The affected lots include #10008320, #10008744, #10008974, #10009342, #10010202, #20001416A, #20001557A, #20001675A, and #20001831A, with expiration dates ranging from 05/16 to 06/18. The product was distributed nationwide.

Consumers should check their medication bottles for the NDC 0115-0533-02 and the specific lot numbers listed above. If the lot number matches, consumers should contact their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

Product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Manufacturer
Impax Laboratories, Inc.
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 (10)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Impax Laboratories, Inc. 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 →

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