The Original Oatly! Oat-Milk 11 fl oz (330ml). UPC 1 90646-63013 3. 18 count case UPC…
Lyons Magnus, Inc recalled this product and the FDA reported the enforcement action on 7 September 2022 as Class I. The recall was initiated by the firm. Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
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
The Original Oatly! Oat-Milk 11 fl oz (330ml). UPC 1 90646-63013 3. 18 count case UPC 20190646630137. Distributed by Oatly Inc., 220 E 42ndSt., Ste. 409A, New York, NY 10017.
UPC
190646630133
Reason for recall
Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
EXPANDED 8-10-2022 Lot Code 1202 / Best By Date 21Jan2023 LM Lot Code 2202 / Best By Date 22Jan2023 LM Lot Code 3231 / Best By Date 19Nov2022 LM Lot Code 4102 / Best By Date 14Jan2023 LM Lot Code 4231 / Best By Date 20Nov2022 LM Lot Code 4531 / Best By Date 20Dec2022 LM Lot Code 5231 / Best By Date 21Nov2022 LM Lot Code 5531 / Best By Date 21Dec2022 LM Lot Code 6402 / Best By Date 15Feb2023 LM Lot Code 7802 / Best By Date 28Mar2023 LM Lot Code 8802 / Best By Date 29Mar2023 LM
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 is one of 77 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 77 separate recalls, which almost every published figure does, overstates it by a factor of 77. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 77 of them.
The recall ran for 2.0 years, from 22 July 2022 to termination on 25 July 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 7 weeks after the firm began the recall.
Recalls of milk or a dairy product run a median of 7 months, so this one was longer than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.
A preventive controls plan covers a botulism risk 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 108.35
Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
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.
21 CFR 113 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.
Recall 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.
