Class ITerminated · reported 2022-12-28

Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by…

UTOPIA FOODS INC recalled this product and the FDA reported the enforcement action on 28 December 2022 as Class I. The recall was initiated by the firm. Product may be contaminated with Listeria monocytogenes.

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
Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by Utopia Foods Inc.; UPC 892891861017; packaged in blue and clear plastic bag
UPC
892891861017
Reason for recall
Product may be contaminated with Listeria monocytogenes.
Recalling firm
UTOPIA FOODS INC
Firm location
Glendale, New York, United States
Classification
Class I
Status
Terminated
Recall number
F-0203-2023
Quantity
Unknown
Distribution
NY, NJ, CA, PA, MA, MD
Initiated
13 December 2022
Reported by FDA
28 December 2022
Terminated
8 December 2023
Firm notified by
Press Release
Product codes
All codes within expiry UPC 892891861017

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 12 months, from 13 December 2022 to termination on 8 December 2023. 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 6 states, and the FDA published the enforcement report 2 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.

Named in the distribution pattern: New York, New Jersey, California, Pennsylvania, Massachusetts, Maryland. 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

Listeria monocytogenes

Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.

A preventive controls plan covers Listeria contamination 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 117.135(c)(3)
Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
21 CFR 117.165(a)(3)
Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

Other records from UTOPIA FOODS INC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 3 records for UTOPIA FOODS INC

All 2022 recalls · All FDA food recall data

21 CFR 117.135(c)(3) 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 access

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.