CLASS II Food recall · Reported 15 Nov 2023 · FDA Enforcement Report

Nutricia KetcoCal 4:1 LQ Unflavored recalled by Nutricia North America

Nutricia North America is recalling Nutricia KetcoCal 4:1 LQ Unflavored, distributed in 21 states. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesExpiration: DEC 10 2023 Batch/Lot 2023.12.10

Quantity recalled283 kits

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-0406-2024
FDA event ID: 93288
Recalling firm: Nutricia North America, Rockville, MD
Brand: Nutricia KetcoCal
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2023
FDA classified: 9 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Product category: Other

Timeline

20 Oct 2023	Recall initiated by company
9 Nov 2023	Classified by FDA	+20 days
15 Nov 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect product in packaging

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*

Where it was distributed

247 kits shipped within US (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) 36 kits shipped within Canada (Ontario, Quebec, Prince Edward, British Columbia, Alberta)

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

Questions about this recall

Is Nutricia KetcoCal 4:1 LQ Unflavored recalled?

Yes. Nutricia North America recalled Nutricia KetcoCal 4:1 LQ Unflavored on 20 Oct 2023. The recall is Class II and its status is Terminated. Recall number F-0406-2024.

Why was it recalled?

Incorrect product in packaging

Which lots are affected?

Expiration: DEC 10 2023 Batch/Lot 2023.12.10

Where was it sold?

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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