Food, drugs, devices › Abbott Laboratories

Food recall: Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton

FDA enforcement event 92015 · Class II · initiated 28 Mar 2023 · status Terminated · terminated 14 Dec 2023

FoodVoluntary: Firm initiated1 product recordColumbus, OH

Abbott Laboratories (Columbus, OH) initiated this food recall on 28 Mar 2023; FDA lists 1 product record under event 92015, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 53% of the 478 food enforcement events initiated in 2023 carry the same class.

Status: Terminated, terminated 14 Dec 2023. Initiation: voluntary: firm initiated. Abbott Laboratories has 46 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Abbott Laboratories, Columbus, OH.

Reason for recall

"Potential of foreign material (hard plastic) within product"

Distribution

"AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV"

Product records

Recall number	Product	Quantity	Class	Status	Report date
F-0698-2023	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	646,668 bars	Class II	Terminated	19 Apr 2023

Context

53%of 2023 food events are Class II478 events that year

1product record in this eventfirm median: 1

46events on this register for the firm

Other enforcement events for Abbott Laboratories

Initiated	Product (first record)	Type	Class	Records
13 Nov 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Device	Class II	1
18 Sep 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t	Device	Class II	1
18 Mar 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software vers	Device	Class II	5
14 Jun 2024	Alinity hq Analyzer, REF: 09P68-01	Device	Class II	1
21 Feb 2024	ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.	Device	Class II	1
31 Oct 2023	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Food	Class II	1
19 Oct 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number	Device	Class II	1
19 Oct 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allow	Device	Class II	3
30 May 2023	Alinity ci-series System Control Module, REF: 03R70-01	Device	Class II	1
24 Nov 2022	Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels	Device	Class III	1

All 46 events for Abbott Laboratories

Questions and answers

Why was this food recalled?

FDA's record gives the reason for recall as: "Potential of foreign material (hard plastic) within product"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Dec 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.