The Recall Desk
HighFDA (Drugs)·D-0773-2018·Announced 2018-05-16

Kroger Recalls Revlimid Due to Lack of Processing Controls

Kroger Specialty Pharmacy is recalling Revlimid 20 mg oral capsules because of a lack of processing controls. The recall affects specific lots distributed in MS, LA, AR, IL, and FL.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is FDA Class II due to a lack of processing controls, which presents a risk of harm where injury has not yet been reported. This aligns with the High severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is voluntarily recalling Revlimid 20 mg oral capsules, NDC 59572-0420-21, due to a lack of processing controls. This defect was identified in units dispensed between December 1, 2017, and February 12, 2018.

The recall covers all lots remaining within their expiry date that were distributed to Mississippi, Louisiana, Arkansas, Illinois, and Florida. The FDA has classified this recall as Class II.

Consumers who may have received these products should contact Kroger Specialty Pharmacy for more information or to return the medication.

The recalled product

Product
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
Category
Drug

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 →