XYMOGEN Recalls LipiChol 540 Medical Food Due to Mislabeling
Atlantic Pro Nutrients is recalling LipiChol 540 because it was labeled as a medical food instead of a dietary supplement.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III and involves a labeling error (medical food vs. dietary supplement) without reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Atlantic Pro Nutrients, Inc. dba XYMOGEN is voluntarily recalling 25,852 bottles of LipiChol 540 (Omega-3 Phospholipid). The product was distributed nationwide, as well as in Alaska, Canada, and China, by PharmaceutiX in Orlando, Florida.
The recall was initiated because the product was labeled as a medical food rather than a dietary supplement. The FDA has classified this recall as Class III, indicating that there is a remote possibility that adverse health consequences could occur.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. The affected lots include #50001784 and #50001783 (exp. 09/2014) and #50002588 and #50002587 (exp. 11/2015).
The recalled product
- Product
- LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
- Manufacturer
- Atlantic Pro Nutrients, Inc. dba XYMOGEN
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 25,852
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Atlantic Pro Nutrients, Inc. dba XYMOGEN under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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