Lipo Escultura Capsule Recall: Unapproved Drug Hazard
FDA recalls LIPO ESCULTURA capsules distributed by JAT Productos Naturales Corp. for being tainted with unapproved drugs sibutramine and diclofenac.
Stop using this now
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
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What happened, in plain English
Lipo Escultura Corp. is recalling all lots of LIPO ESCULTURA capsules, 250 mg in 60-count bottles, because the product is marketed as a dietary supplement but contains unapproved prescription drugs. The capsules were found to be tainted with sibutramine, an appetite suppressant withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug. Because these substances are not approved for use in dietary supplements, the product is considered an unapproved drug. Read more at govinfonow.com/recall/43348-lipo-escultura-corp-recalls-lipo-escultura-capsules-250-mg-60.
Source Summary by GovInfoNow · govinfonow.com/recall/43348-lipo-escultura-corp-recalls-lipo-escultura-capsules-250-mg-60 · Updated October 11, 2026 · FDA enforcement record: FDA #D-0860-2016
Cite this page
“Lipo Escultura Capsule Recall: Unapproved Drug Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43348-lipo-escultura-corp-recalls-lipo-escultura-capsules-250-mg-60. Based on FDA recall #D-0860-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0860-2016%22&limit=1).
Why it’s dangerous
The product contains sibutramine, which was removed from the U.S. market due to safety concerns, and diclofenac, a prescription NSAID. Ingesting these unapproved drugs poses health risks that are not disclosed on the label of a dietary supplement.
Who’s affected
Consumers who purchased LIPO ESCULTURA capsules from JAT Productos Naturales Corp. via internet sales nationwide are affected. Individuals seeking weight loss or pain relief through dietary supplements are most at risk of ingesting unapproved pharmaceutical ingredients.
How to tell if you have this one
Look for LIPO ESCULTURA capsules in 250 mg strength, packaged in 60-count bottles. The product was distributed by JAT Productos Naturales Corp., located in Brooklyn, NY 11238, and sold nationwide via the internet at www.lipoesculturatreatment.com. All lots are included in this recall.
- Brand
Lipo Escultura- Category
Drug
What to do — step by step
Stop using the product
Do not consume any remaining capsules from the recalled lots due to the presence of unapproved drugs.
Discard or return the item
The recall record does not specify a specific remedy such as a refund or replacement, so consumers should dispose of the product safely.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide via Internet sales” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Contact Lipo Escultura
We’ve drafted a message you can send Lipo Escultura to request your refund or repair — edit it as you like.
Subject: Recall D-0860-2016 — Lipo Escultura Capsule Recall: Unapproved Drug Hazard Hello, I own a Lipo Escultura Capsule Recall: Unapproved Drug Hazard that is covered by recall D-0860-2016 from Lipo Escultura. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0860-2016 (December 3, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0860-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.