LipiChol 540 (XYMOGEN) – Incorrect Labeling (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Brand
Atlantic Pro Nutrients, Inc. dba XYMOGEN
Lot Codes / Batch Numbers
UPC # N3 53731-001-06 9 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015
Products Sold
UPC # N3 53731-001-06 9 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015
Atlantic Pro Nutrients, Inc. dba XYMOGEN is recalling LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: Pharmaceut due to Product was labeled as a medical food as opposed to a dietary supplement.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was labeled as a medical food as opposed to a dietary supplement.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 6, 2026