The Recall Desk
LowFDA (Food)·F-0815-2014·Announced 2014-01-08

XYMOGEN LipiChol Medical Food Recalled for Incorrect Product Classification

Atlantic Pro Nutrients is recalling 25,852 bottles of LipiChol and related brands because the product was labeled as a medical food instead of a dietary supplement.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a labeling error regarding product classification rather than a physical hazard.

Plain-English summary

Atlantic Pro Nutrients, Inc. dba XYMOGEN is recalling 25,852 bottles of XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) and 48 other related brands. The recall was initiated because the product was labeled as a medical food as opposed to a dietary supplement.

The affected products were distributed nationwide, as well as in Alaska, Canada, and China. Specific lot numbers include 50001784, 50001783, 50002588, and 50002587, with expiration dates in September 2014 and November 2015. The products are identified by UPC numbers 8 71149 00375 3 and 8 71149 00891 8.

Consumers should stop using the product and return it to the place of purchase for a refund or follow instructions provided by the recalling firm.

The recalled product

Product
XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metaboli
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 # 8 71149 00375 3 and UPC # 8 71149 00891 8 Lot # 50001784 exp. 09/2014
  • lot # 50001783 exp. 09/2014
  • lot # 50002588 exp 11/2015
  • and lot # 50002587 exp. 11/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Atlantic Pro Nutrients, Inc. dba XYMOGEN

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