Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper…
Nutricia North America recalled this product and the FDA reported the enforcement action on 15 November 2023 as Class II. The recall was initiated by the firm. Incorrect product in packaging
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*
- Reason for recall
- Incorrect product in packaging
- Recalling firm
- Nutricia North America
- Firm location
- Rockville, Maryland, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0406-2024
- Quantity
- 283 kits
- Distribution
- 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)
- Initiated
- 20 October 2023
- Reported by FDA
- 15 November 2023
- Terminated
- 18 September 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Expiration: DEC 10 2023 Batch/Lot 2023.12.10
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 11 months, from 20 October 2023 to termination on 18 September 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 4 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Other records from Nutricia North America
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-07-22 | functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2 | Nutricia North America | Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product. | Class II |
| 2026-07-22 | functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2 | Nutricia North America | Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product. | Class II |
| 2023-06-28 | TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case. | Nutricia North America | Infant formula contains undeclared tyrosine | Class II |
| 2018-01-17 | SHS Wel-Plan Wheat and Corn Strach Baking Mix , 400 g box,Cardboard carton, 18 cartons per case, but distributed by individual unit (carton). | Nutricia North America | Nutricia North America, Inc. has decided to recall SHS Wel-Plan Baking Mix , 400 g box because testing of the product has detected a low level (0.74 cfu/g) contamination of Klebsiella pneumonia. The product is a baking mix and is intended to be cooked, which would kill K. pneumonia. The recall is being conducted out of an abundance of caution to avoid the risk that some consumers may misuse the product and consume it without cooking. | Class II |
All 5 records for Nutricia North America
All 2023 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.