Food recall: Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and…
Class II FDA enforcement event 66821. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Ortho Molecular Products' vegetable enzyme vendor issued a recall of the raw material due to potential chloramphenicol contamination.
Class II, in the words of FDA
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
Ortho Molecular Products Inc started this food recall on 7 Nov 2013. The firm address in the FDA record is in Stevens Point, WI. FDA put the recall in Class II. FDA event 66821 has 1 product record. The first FDA enforcement report date is 4 Dec 2013. The record gives the status Terminated, with the termination date 25 Apr 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
nationwide. Outside the U.S. to include China and Mexico.
Recalling firm
Ortho Molecular Products Inc, Stevens Point, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0348-2014 | Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U). | 52,921 bottles | Class II | Terminated | 4 Dec 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2013
- 546
- Share of these events in Class II
- 52%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Jan 2023 | Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molec | Food | Class II | 1 |
| 1 Aug 2014 | Ortho Molecular Products LifeCORE, Rich Dark Chocolate, Dietary Supplement Net Wt. 732.2 Grams (25.8Oz), Product #927001 | Food | Class I | 2 |
Official channels
- FDA enforcement report F-0348-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 66821. https://recallregister.com/fda/ii/66821/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
nationwide. Outside the U.S. to include China and Mexico.
- What quantity of product is in FDA event 66821?
- The FDA record gives this quantity:
52,921 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2013 have the same class?
- 52% of the 546 food events that started in 2013 are in Class II.