Class IIITerminated · reported 2023-07-05

1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an amber glass bottle; 2.

Anatox Inc recalled this product and the FDA reported the enforcement action on 5 July 2023 as Class III. The recall was initiated by the firm. Elevated lead levels

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: 1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an amber glass bottle; 2. Sonne's Calphonite #2, 15 Fl. oz. (444 ml) in an amber glass bottle
Reason for recall: Elevated lead levels
Recalling firm: Anatox Inc
Firm location: Richland, Missouri, United States
Classification: Class III
Status: Terminated
Recall number: F-1005-2023
Quantity: 6,777 bottles
Distribution: Distributors, retailers, and consumers in AL, AZ, CA, CT, CO, FL, GA, IL, IN, KS, KY, MA, MD, MN, MO, NC, NM, NY, OH, OR, PA, TN, TX, UT, VA, VT, WI
Initiated: 26 May 2023
Reported by FDA: 5 July 2023
Terminated: 4 October 2023
Firm notified by: Letter
Product codes: 1. 030724-1; 030824-2; 030824-3; 040524-1; 040624-2; 051024-1; 051124-2 2. 030924-4; 031024-5; 080824-1

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 4 months, from 26 May 2023 to termination on 4 October 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 26 states, and the FDA published the enforcement report 6 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: Arizona, California, Connecticut, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin. 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

Chemical contamination

A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.

A preventive controls plan covers chemical 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 117.35(b): Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
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.
21 CFR 117.130(b)(1)(ii): Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.

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 92186
Reported	Product	Firm	Reason	Class
2023-07-05	Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber glass bottle.	Anatox Inc	Elevated lead levels	Class III

Other records from Anatox Inc

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

Reported	Product	Firm	Reason	Class
2023-07-05	Sonne's Detoxificant #7, 1 quart (946 mL) packaged in amber glass bottle.	Anatox Inc	Elevated lead levels	Class III

All 2023 recalls · All FDA food recall data

21 CFR 117.35(b) 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.