Recall Register

Food, drugs, devices

Food recall: New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.ne

FDA enforcement event 65783 · Class II · initiated 22 Jul 2013 · status Terminated · terminated 21 Nov 2013

FoodVoluntary: Firm initiated2 product recordsHendersonville, NC

New Sun Inc (Hendersonville, NC) initiated this food recall on 22 Jul 2013; FDA lists 2 product records under event 65783, 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. 52% of the 546 food enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 21 Nov 2013. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for New Sun Inc.

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

Recalling firm

New Sun Inc, Hendersonville, NC.

Reason for recall

"Positive E.coli"

Distribution

"AL, CA, CO, FL GA, HI, ID, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, OH, PA, RI, SC, SD, TN, TX, VA, WA"

Product records

Recall numberProductQuantityClassStatusReport date
F-1880-2013New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.newsun.net Product No. 78-138,900 capsulesClass IITerminated18 Sep 2013
F-1881-2013New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New Sun, Inc, Hendersonville NC 28792 1-800-544-0777 www.newsun.net product No. 74-061,840 capsulesClass IITerminated18 Sep 2013

Context

52%of 2013 food events are Class II546 events that year
2product records in this event
1event on this register for the firm

Questions and answers

Why was this food recalled?

FDA's record gives the reason for recall as: "Positive E.coli"

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, CA, CO, FL GA, HI, ID, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, OH, PA, RI, SC, SD, TN, TX, VA, WA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Nov 2013. "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.