Class IITerminated · reported 2025-02-12

item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB

FGF, LLC recalled this product and the FDA reported the enforcement action on 12 February 2025 as Class II. The recall was initiated by the firm. potential for contamination 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: item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB
Reason for recall: potential for contamination with listeria monocytogenes
Recalling firm: FGF, LLC
Firm location: Brownsburg, Indiana, United States
Classification: Class II
Status: Terminated
Recall number: F-0482-2025
Quantity: 2,017,614 cases total
Distribution: Nationwide US and Canada
Initiated: 7 January 2025
Reported by FDA: 12 February 2025
Terminated: 23 April 2025
Firm notified by: Letter
Product codes: All product within expiration produced 12/13/24 and prior

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 60 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 60 separate recalls, which almost every published figure does, overstates it by a factor of 60. 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 60 of them.
The recall ran for 3 months, from 7 January 2025 to termination on 23 April 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 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.

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 FGF, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 59 other records name this firm.

Reported	Product	Firm	Reason	Class
2025-02-12	item 8201866 JUST BAKED PUMPKIN CAKE RINGS 144x2.45 OZ, NET WT 22.05 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201886 FLAVOREDSOUR CREAM CAKE DONUT 72x3OZ, NET WT 12.15 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.16 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201807 BAVARIAN FILLED DONUT 78x2.75OZ, NET WT 12.07 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201919 BAR YST DONUT UNFLD PFD 74x3OZ, NET WT 12.49 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201846 GEN CHOC HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201844 GEN GLD PERSIAN DONUT DGH FRZ 132x2.5OZ, NET WT 18.56 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201906 JUST BAKED CAKE STICKS 116x2.9 OZ, NET WT 21.03 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201927 APPLE FRITTER DONUT PFD 70 X 3.5OZ, NET WT 13.78 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II
2025-02-12	item 8201860 JUST BAKED SOUR CREAM CAKE DONUTS 120x2.5 OZ, NET WT 18.75 LB	FGF, LLC	potential for contamination with listeria monocytogenes	Class II

All 60 records for FGF, LLC

All 2025 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.