Class IITerminated · reported 2024-10-02

Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China…

Niitakaya USA Inc recalled this product and the FDA reported the enforcement action on 2 October 2024 as Class II. The recall was initiated by the firm. Undeclared allergen (Fish) Ingredient

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
Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3700
Reason for recall
Undeclared allergen (Fish) Ingredient
Recalling firm
Niitakaya USA Inc
Firm location
Montebello, California, United States
Classification
Class II
Status
Terminated
Recall number
F-1833-2024
Quantity
9,482 units
Distribution
Affected products were distributed in 7 states (AZ, CA, GA, HI, NJ, TX, WA) with 47 direct consignees.
Initiated
29 August 2024
Reported by FDA
2 October 2024
Terminated
5 March 2025
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Best By Dates: 12/25/24 through 08/11/25

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 is one of 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
  • The recall ran for 6 months, from 29 August 2024 to termination on 5 March 2025. 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 5 states, and the FDA published the enforcement report 5 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: California, Georgia, Hawaii, New Jersey, Texas. 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

Undeclared allergens

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

A preventive controls plan covers an undeclared allergen 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)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

The allergens named in this record: fish.

Every product in this recall

The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 1 records of FDA event 95293
ReportedProductFirmReasonClass
2024-10-02Miso Katsuo Ninniku (Pickled Garlic), Net WT 5.2 OZ (147g) Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3701Niitakaya USA IncUndeclared allergen (Fish) IngredientClass II

Other records from Niitakaya USA Inc

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

ReportedProductFirmReasonClass
2024-10-02Miso Katsuo Ninniku (Pickled Garlic), Net WT 5.2 OZ (147g) Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3701Niitakaya USA IncUndeclared allergen (Fish) IngredientClass II

All 2024 recalls · All FDA food recall data

21 CFR 117.135(c)(2) 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.