The Recall Desk
HighFDA (Food)·F-0406-2024·Announced 2023-11-15

Nutricia KetcoCal 4:1 Recall: Incorrect Product in Packaging

Nutricia is recalling KetcoCal 4:1 LQ Unflavored sample kits due to incorrect product in packaging. A total of 283 kits distributed to the US and Canada expire December 10, 2023.

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: FDA Class II recall of a medical food product with incorrect product in packaging. This is a risk-of-harm scenario for patients dependent on the correct formulation for medically supervised ketogenic diet management, though no illnesses have been reported.

Plain-English summary

Nutricia North America is recalling KetcoCal 4:1 LQ Unflavored sample kits in 237ml tetra prisma cartons (3 per box) because they contain incorrect product in packaging.

KetcoCal 4:1 is a specialized medical food for patients following medically supervised ketogenic diets. Receiving an incorrect product could affect the health and nutrition of patients dependent on this specific formulation.

A total of 283 sample kits were distributed: 247 within the United States (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin) and 36 within Canada (Ontario, Quebec, Prince Edward Island, British Columbia, Alberta). The affected lots expire December 10, 2023, with lot number 2023.12.10.

If you received one of these sample kits, do not use the product. Contact Nutricia North America for replacement or additional information.

The recalled product

Product
Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*
Manufacturer
Nutricia North America
Category
Food — Medical Food / Ketogenic
Hazard
  • product-mislabeling

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)

  • Expiration: DEC 10 2023 Batch/Lot 2023.12.10

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category