The Recall Desk
ModerateFDA (Drugs)·D-0775-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Revlimid Capsules Due to Processing Controls

Kroger Specialty Pharmacy is recalling Revlimid 25 mg oral capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Revlimid 25 mg oral capsules (NDC 59572-0425-21, 28-day supply) because of a lack of processing controls. The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.

The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply

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 (1)

  • All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, 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 67 products in this recall →