The Recall Desk
ModerateFDA (Drugs)·D-0787-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Sutent 37.5 mg Capsules Due to Processing Controls

Kroger Specialty Pharmacy is recalling Sutent 37.5 mg capsules due to a lack of processing controls. The affected products were dispensed in five states 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, but the source text explicitly states no illnesses or injuries are reported and the hazard is a lack of processing controls, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Sutent 37.5 mg capsules (NDC 00069-0830-38) in 28-day supply packages. The recall is being conducted due to a lack of processing controls.

The affected products were dispensed between December 1, 2017, and February 12, 2018. The recall covers all lots remaining within their expiration date that were dispensed during this period. Distribution was limited to Mississippi, Louisiana, Arkansas, Illinois, and Florida.

Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to proceed. The source text does not specify reported illnesses or injuries associated with this recall.

The recalled product

Product
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 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 →