Severity
Low
LowClass IIITerminated
FDA Food recall · Reported January 8, 2014
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Product was labeled as a medical food as opposed to a dietary supplement.
Atlantic Pro Nutrients, Inc. dba Xymogen recalled LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by:… - a low-severity action.
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by:… was recalled by Atlantic Pro Nutrients, Inc. dba Xymogen in January 8, 2014. Reason: Product was labeled as a medical food as opposed to a dietary supplement.. Check the official notice for the remedy. Verify recall #F-0816-2014 with the FDA Food before acting.
The recall
Atlantic Pro Nutrients, Inc. dba Xymogen issued this low-severity FDA Food recall-Product was labeled as a medical food as opposed to a dietary supplement..
- Low
- severity level
- Class III
- classification
- January 8, 2014
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0816-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0816-2014) was formally reported on January 8, 2014, with the manufacturer initiating the action on August 16, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Atlantic Pro Nutrients, Inc. dba Xymogen is listed as the recalling firm, operating out of Orlando, FL. Federal records list the affected scope as 25,852 bottles (All Brands).
The documented reason for this recall is: Product was labeled as a medical food as opposed to a dietary supplement. Distribution data in the federal record shows the product reached: Nationwide and Alaska Canada and China. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25,852 bottles (All Brands)
Related Recalls
6
2 from same agency
Product description
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Reason for recall
Product was labeled as a medical food as opposed to a dietary supplement.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | F-0816-2014 |
| Date reported | January 8, 2014 |
| Date initiated | August 16, 2013 |
| Recalling firm | Atlantic Pro Nutrients, Inc. dba Xymogen |
| Firm location | Orlando, FL |
| Affected scope | 25,852 bottles (All Brands) |
| Distribution | Nationwide and Alaska Canada and China |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0816-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida. Recalled by Atlantic Pro Nutrients, Inc. dba Xymogen. Units affected: 25,852 bottles (All Brands).
Why was this product recalled? ▼
Product was labeled as a medical food as opposed to a dietary supplement.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on January 8, 2014. Severity: Low. Recall number: F-0816-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Alaska Canada and China.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0816-2014) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported January 8, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.