Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12…
SunOpta Grains and Foods Inc. recalled this product and the FDA reported the enforcement action on 9 February 2022 as Class II. The recall was initiated by the firm. Product that did not meet quality standards was released in error. Complaints of spoilage received.
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
- Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count consumer display case) SunOpta Item number 1243803 Individual Carton UPC: 0 96619 99861 6; 12 x 32 oz. container carton UPC: 096619 49000 4 Ambient, keep refrigerated after opening. Best if used within 7 10 days after opening, not to be used as infant formula. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124
- UPC
- 096619998616
- Reason for recall
- Product that did not meet quality standards was released in error. Complaints of spoilage received.
- Recalling firm
- SunOpta Grains and Foods Inc.
- Firm location
- Eden Prairie, Minnesota, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0631-2022
- Quantity
- 11821341E - 8112 cases; 11821342E - 3963 cases
- Distribution
- AZ, CA, WA
- Initiated
- 26 January 2022
- Reported by FDA
- 9 February 2022
- Terminated
- 11 May 2022
- Firm notified by
- Telephone
- Product codes
- 07 DEC 2022 11821341E XX:XX; 08 DEC 2022 11821342E XX:XX
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 3 months, from 26 January 2022 to termination on 11 May 2022. 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 distribution pattern names 3 states, and the FDA published the enforcement report 2 weeks after the firm began the recall.
- Recalls of infant formula or baby food run a median of 10 months, so this one was shorter than usual for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.
Named in the distribution pattern: Arizona, California, Washington. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Filed under infant formula and baby food, milk and dairy and beverages and juice. A product can sit in more than one.
Other infant formula and baby food recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from SunOpta Grains and Foods Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 17 other records name this firm.
All 18 records for SunOpta Grains and Foods Inc.
All 2022 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one 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.