Aqualyx vs Lemon Bottle: ingredients, evidence and regulator warnings

Not yet medically reviewed. Fact-checked against the sources listed below on October 7, 2026.How we write and review

Last updated October 7, 2026

Aqualyx is described in papers as a deoxycholate-based injection sold in Europe as a medical device, with small uncontrolled studies. Lemon Bottle is declared to contain bromelain, lecithin and riboflavin, but Swissmedic found samples did not match the label, and no published study was found. Neither has an FDA Philippines drug registration.

Key takeaways

Aqualyx is described in published papers as a deoxycholate-based solution and a CE-marked medical device in Europe. Lemon Bottle is declared to contain mainly bromelain, lecithin and riboflavin.
Aqualyx has uncontrolled case series, several by authors who advise its distributors. No study of any kind on Lemon Bottle was found.
Swissmedic found that Lemon Bottle samples did not match their declared ingredients and says they can be regarded as falsifications.
FDA Philippines Advisory No.2023-0164 names Aqualyx Cosmetic Sterile as an unregistered drug product. No FDA Philippines advisory naming Lemon Bottle was found.
Neither is the approved drug Kybella (deoxycholic acid), which the US FDA has approved only for fat under the chin.

Side by side

	Aqualyx	Lemon Bottle
Class	Injectable lipolysis product: a deoxycholate-based aqueous gel solution injected into fat ("intralipotherapy"), described in published papers as a CE-marked medical device in Europe, not as an approved medicine. Not a peptide. Distinct from Kybella or Belkyra (deoxycholic acid injection), which is an approved prescription drug in the US and Canada	Branded "fat dissolving" solution (injectable lipolysis product as marketed online and on social media); declared to contain mainly bromelain, lecithin and riboflavin. Not a peptide, and Swissmedic says it is not authorised in Switzerland
FDA Philippines registration	No FDA Philippines drug or medical device registration for Aqualyx was found in the verification portal on 2026-10-07. FDA Philippines Advisory No.2023-0164 names Aqualyx Cosmetic Sterile as an unregistered drug product. Three Aqualyx-branded products appear as notified cosmetics with face and body care intended uses	No FDA Philippines drug registration for Lemon Bottle was found in the verification portal on 2026-10-07. One product branded LEMONBOTTLE appears as a notified cosmetic, with the intended use face and body contouring plus moisturizing. No FDA Philippines advisory or statement naming Lemon Bottle was found
Evidence	Small human studies	No published studies found
Prescription needed	Not confirmed	Not confirmed
Registration source date	Checked October 7, 2026	Checked October 7, 2026

What is each product said to contain?

Neither product's contents have been confirmed by a regulator. What is known comes from published papers (Aqualyx) and from the label as reported by Swissmedic (Lemon Bottle).

	Aqualyx	Lemon Bottle
Described as	"A deoxycholate, aqueous gelatinous solution mixed with saline and buffering compounds"	"Primarily bromelain, lecithin and riboflavin, in addition to a number of natural ingredients"
Who says so	Authors of a 2022 case report	The package and internet claims, as reported by Swissmedic
Origin or distributor	Developed in Italy, commercially available since 2009, per the same case report	A distributor in Seoul, Korea, per Swissmedic
Proposed action	Deoxycholate destroys fat cells ("adipocytolysis"), per a review by authors who advise its distributors	No regulator or peer-reviewed source describes how it would work
Regulator test of contents	None in the sources checked	Swissmedic found samples did not match the declaration

What the Lemon Bottle distributor says

Swissmedic reports that the distributor "emphasises that the original Lemon Bottle Ampoule solution is exclusively for external use as a cosmetic and not intended for lipolysis or injection". The distributor also says it could not verify that Swissmedic's samples were original. Swissmedic replies that Lemon Bottle products intended for injection "are still considered to be a medicinal product".

How does their regulatory status compare?

Neither is an approved medicine in the sources found. They are classed differently.

	Aqualyx	Lemon Bottle
Europe	Described in papers as "a Class III CE-marked medical device (approved in 2009)" for localized fat with ultrasound therapy. No EU regulator source was found	Swissmedic classes the lipolysis solution as a medicinal product based on its composition and because it is injected; not authorised in Switzerland
Disputes	A 2017 letter calls its device status an "anomaly", as it is a deoxycholate solution. Other papers describe it inconsistently	The distributor says the original product is a cosmetic for external use only
US FDA	Named on the FDA consumer page as an unapproved fat-dissolving injection	Not among the brands named on that page

Evidence compared

Aqualyx has a small body of uncontrolled studies. Lemon Bottle has none.

	Aqualyx	Lemon Bottle
Randomized controlled trials	None found; no study registered on ClinicalTrials.gov	None found
Other human data	Case series and retrospective reports, for example 1,832 patients in a 2016 multicentre report and 186 in a 2015 report	No human study or case report found
Animal or lab studies	Not searched in depth	None found
Conflicts of interest	In the 2016 report, all authors but one advise Aqualyx distributors	Not applicable

In the 2016 Aqualyx report, doctors judged treatment a success in 76.7% of cases and patients in 67.2%. There was no control group.

For Lemon Bottle, Swissmedic states: "No medicinal effect has been scientifically proven".

Risks compared

Regulators have raised risk concerns about both, but the kind of information differs.

	Aqualyx	Lemon Bottle
Reported in studies	In 186 patients: swelling and redness in all (3 to 5 days), itching 21.5%, bruising 6.45%, nodules 1.61%, paresthesia 1.07%	No study found
Case reports	Skin necrosis; infected, painful nodules after a product "advertised as Aqualyx" given by someone who was not a trained health professional	None found in PubMed or Europe PMC
Quality concerns	None in the sources checked	Swissmedic reported that in one sample the only substance found was caffeine, and that in another none of the listed ingredients could be detected, and calls them falsifications
Regulator statements	US FDA: reports of "permanent scars, serious infections, skin deformities, cysts, and deep, painful knots" after unapproved fat-dissolving injections	Swissmedic: use "may therefore pose a health risk". UK GPhC: concerns that such products "have potentially caused serious harm"

Regulator warnings compared

Regulator	Aqualyx	Lemon Bottle
FDA Philippines	Advisory No.2023-0164 (27 January 2023) names "Aqualyx® Cosmetic Sterile" as an unregistered drug product	No advisory naming Lemon Bottle found
US FDA	Named on the consumer page on unapproved fat-dissolving injections	Not named
Swissmedic	Not recorded	Warning dated 26 March 2024; "expressly warns against using" it
UK GPhC	Not recorded	Named in its 2025 concerns about unregulated products supplied by pharmacies

PH status compared

Neither has an FDA Philippines drug registration. A search of the verification portal on 7 October 2026 found:

	Aqualyx	Lemon Bottle
Drug registrations	None	None
Medical device records	None	Not recorded
Cosmetic notifications	3 Aqualyx-branded products for face and body care	1 LEMONBOTTLE product for face and body contouring plus moisturizing
FDA Philippines advisory naming it	No.2023-0164	None found

A cosmetic notification is not a drug registration.

FDA Philippines has also warned against other unregistered products of these kinds that are neither Aqualyx nor Lemon Bottle. These include an ampoule solution labelled "Lecithin + Bromelain + Vitamin" (Advisory No.2026-1281) and injectable products of the same type as Aqualyx in 2026. In May 2026, an NBI operation in Pasig City with FDA support reportedly apprehended a medical practitioner giving unregistered injectables, including fat-dissolving products. FDA did not name the products.

How do both compare with Kybella?

Kybella is a different product from both. It is deoxycholic acid injection, which the US FDA approved on 29 April 2015 for moderate to severe fat under the chin in adults. The US FDA says it is the only fat-dissolving injectable drug it has approved.

Aqualyx and Kybella are both based on deoxycholate, but Kybella's approval and trial results do not apply to Aqualyx. Lemon Bottle is declared to contain different ingredients.

Frequently asked questions

What is the difference between Aqualyx and Lemon Bottle?

Aqualyx is described in published papers as a deoxycholate-based solution injected into fat, sold in Europe as a CE-marked medical device. Lemon Bottle is a branded solution declared to contain mainly bromelain, lecithin and riboflavin. Swissmedic's tests could not confirm Lemon Bottle's declared ingredients.

Which is approved, Aqualyx or Lemon Bottle?

Neither is an approved medicine in the sources found. Aqualyx is reported in papers as a CE-marked device in Europe. Swissmedic says Lemon Bottle lipolysis solution is not authorised in Switzerland and "may not be sold, dispensed or used" there.

Is there more evidence for Aqualyx or Lemon Bottle?

Aqualyx has a few uncontrolled case series, several by authors linked to its distributors, and no randomized trial. For Lemon Bottle, searches of PubMed, Europe PMC and ClinicalTrials.gov found no human trial, animal study or case report.

Are Aqualyx and Lemon Bottle registered with FDA Philippines?

Neither has a drug registration in the FDA Philippines verification portal (searched 7 October 2026). Aqualyx-branded and LEMONBOTTLE products appear only as notified cosmetics. A cosmetic notification is not a drug registration. Advisory No.2023-0164 names Aqualyx Cosmetic Sterile as an unregistered drug product.

Has FDA Philippines warned against Lemon Bottle like it did Aqualyx?

No FDA Philippines advisory naming Lemon Bottle was found on 7 October 2026. Advisory No.2023-0164 names Aqualyx Cosmetic Sterile. FDA Philippines has also warned against other unregistered products, including one labelled with lecithin and bromelain (Advisory No.2026-1281), but these are different products.

What side effects have been reported with Aqualyx and Lemon Bottle?

For Aqualyx, case series report swelling, redness, itching, bruising and nodules, and case reports describe skin necrosis. No published case report linked to Lemon Bottle was found, but the UK pharmacy regulator has received concerns that such products "have potentially caused serious harm."

Does the US FDA mention Aqualyx or Lemon Bottle?

The US FDA consumer page on unapproved fat-dissolving injections names Aqualyx among the brands sold online. Lemon Bottle is not among the brands it names.

Are Aqualyx or Lemon Bottle the same as Kybella?

No. Kybella is deoxycholic acid injection, a prescription drug the US FDA approved in 2015 for fat under the chin in adults. Its trial results apply only to Kybella.

Are Aqualyx or Lemon Bottle for weight loss?

Aqualyx is described for localized fat, not body weight, and a 2016 Aqualyx report excluded patients whose weight changed by more than 5%. Swissmedic says Lemon Bottle is not authorised in Switzerland, and no published study of it was found.

Sources

This content is for education only and is not medical advice. Talk to a licensed doctor before starting any treatment.