Severity
Low
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Reported: January 8, 2014 Initiated: August 16, 2013 #F-0816-2014 25,852 bottles (All Brands) units
Atlantic Pro Nutrients, Inc. dba XYMOGEN issued this FDA Food recall on January 8, 2014. Classified as Low severity (Class III). Approximately 25,852 bottles (All Brands) units are affected. The recall was issued because: Product was labeled as a medical food as opposed to a dietary supplement.. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
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 indicate 25,852 bottles (All Brands) units are affected.
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.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
25,852 bottles (All Brands)
Related Recalls
6
6 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.
Details
- Recalling Firm
- Atlantic Pro Nutrients, Inc. dba XYMOGEN
- Units Affected
- 25,852 bottles (All Brands)
- Distribution
- Nationwide and Alaska Canada and China
- Location
- Orlando, FL
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 |
| Units affected | 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.
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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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).