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Neurotoxins

Botox Cosmetic

AbbVie (Allergan Aesthetics)

Licensed biologic (FDA)Checked Sep 14, 2026 · Read on the pages cited

What it is

Maker
AbbVie (Allergan Aesthetics)
Category
Neurotoxins
Also called
Botox, onabotulinumtoxinA, BOTOX Cosmetic

FDA status

Pathway
Licensed biologic (FDA)
First approved or cleared
1989

Research notes

BOTOX COSMETIC (50 and 100 Units/vial) is listed under BLA 103000 together with therapeutic BOTOX (50/100/200 Units/vial). The year shown is the label's 'Initial U.S. Approval: 1989' for onabotulinumtoxinA; Drugs@FDA shows 1991-12-09 as the original approval date of application 103000. The year the cosmetic glabellar-line indication was first approved was not confirmed on an opened page. The platysma-band indication appears in the label revised 2024-10-18 (Drugs@FDA supplement 5331, efficacy-new indication, approved 2024-10-18). The 200-unit vial named in FDA's counterfeit alert is therapeutic BOTOX, not BOTOX Cosmetic.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Temporary improvement in the appearance of moderate to severe glabellar (frown) lines between the eyebrows in adults
  • Temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet) in adults
  • Temporary improvement in the appearance of moderate to severe forehead lines in adults
  • Temporary improvement in the appearance of moderate to severe platysma bands (vertical neck bands) in adults

How it’s sold

Units; single-dose vials of 50 Units or 100 Units of vacuum-dried powder that is reconstituted before injection

Not interchangeable

The label states: "Units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method."

What the label warns about

Checking it’s the real thing

  • FDA alert: counterfeit Botox was found in multiple states and given to consumers for cosmetic purposes, with hospitalizations reported. Genuine product shows the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial and comes in 50-, 100- or 200-unit vials. Counterfeit signs named by FDA: lot number C3709C3, carton listing "Botulinum Toxin Type A", a 150-unit dose, or non-English carton text. FDA advises getting injections only from a licensed, trained provider using product from an authorized source (alert updated 2024-05-01).

    FDA: Counterfeit Version of Botox Found in Multiple States (opens in a new tab) · published Apr 16, 2024 · checked Sep 14, 2026

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Compare the carton

Does the Botox carton match FDA’s counterfeit notice?

Enter what is printed on the outer carton or vial. It is compared with FDA’s own words, here in this browser. Nothing is sent, and a photo is never needed. This can find a sign FDA listed; it cannot show a vial is genuine.

Printed next to LOT on the carton and the vial.

Active ingredient as printed

Product named on the carton

Units per vial

Manufacturer on the carton

Language on the outer carton

Enter what is printed on the carton or vial to compare it with FDA’s notice.

What FDA’s notice says, word for word

The counterfeit may be identified by one or more of:

  • “the outer carton and vial contain lot number C3709C3”
  • “the outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA””
  • “the outer carton and vial indicates 150-unit doses, which is not a unit made by AbbVie or Allergan”
  • “the outer carton contains language that is not English”

What FDA says the genuine product shows:

“FDA-approved Botox is available in 100- and 200-unit vials. FDA-approved Botox Cosmetic is available in 50- and 100-unit vials. The FDA-approved Botox products display the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.”

“The product description on the outer carton is one of the following: “BOTOX® COSMETIC / onabotulinumtoxinA / for injection” or “OnabotulinumtoxinA / BOTOX® / for injection”.”

“The manufacturer identified on the outer carton is one of the following: “Allergan Aesthetics / An AbbVie Company”, “Allergan”, “abbvie”.”

“FDA is aware of adverse events, including hospitalizations, linked to the counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head following injection of these products.”

“Consumers should report suspected counterfeit Botox products to FDA at 800-551-3989, or through the Report Suspected Criminal Activity database.”

Counterfeit Version of Botox Found in Multiple States (opens in a new tab) · FDA, Drug Alerts and Statements · posted Apr 16, 2024, updated May 1, 2024 · checked Sep 25, 2026

Recalls and enforcement

FDA recall and enforcement records filed under BLA 103000, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up BLA 103000 and a number from the box

What changed at the source

Dated FDA records that concern Botox Cosmetic, newest first. A record says what happened at the source; it is not a finding about any clinic's stock.

  1. Enforcement or recall ·

    FDA warning letter to a Texas med spa over Botox from unauthorized sources

    U.S. Food & Drug Administration · FDA warning letter 723267

    A CDER warning letter dated April 1, 2026 said a med spa obtained botulinum toxin from entities that were not authorized trading partners and claimed it was authentic AbbVie Botox; FDA's laboratory analysis found botulinum neurotoxin type A in an unlabeled vial at the facility.

    What this source establishes
    That FDA found one named med spa sourced toxin outside the authorized supply chain while presenting it as Botox.
    What it does not establish
    Anything about any other clinic. It is why "where was this vial bought?" is a fair question to ask.

    The official record (opens in a new tab) · checked Sep 25, 2026

  2. Enforcement or recall ·

    FDA warned 18 websites selling unapproved botulinum toxin

    U.S. Food & Drug Administration · FDA news release, 2025-11-05

    FDA issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, and restated that FDA-approved botulinum toxin products are available only with a prescription and should come from an authorized source.

    What this source establishes
    That FDA acted against specific websites selling unapproved or misbranded botulinum toxin, and that approved products are prescription-only.
    What it does not establish
    Whether a particular clinic's vial is genuine or where it was bought. The carton, the vial and the practice's supplier are what speak to that.

    The official record (opens in a new tab) · checked Sep 25, 2026

  3. Safety communication ·

    FDA alert: counterfeit Botox found in multiple states

    U.S. Food & Drug Administration · FDA drug alert, 2024-04-16 (updated 2024-05-01)

    FDA reported counterfeit Botox given to consumers, with hospitalizations. FDA's markers of the counterfeit: lot number C3709C3, the active ingredient printed as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA", a 150-unit vial, and non-English text on the carton. Updated May 1, 2024 with images of the authentic cartons.

    What this source establishes
    What FDA says the counterfeit and the authentic cartons and vials show, and that FDA advises confirming the product came from an authorized source.
    What it does not establish
    That a vial without those markers is genuine. Only an authorized supply chain establishes that, and a photograph cannot.

    The official record (opens in a new tab) · checked Sep 25, 2026

Check it yourself

Injectable drug proof ladder: The service uses botulinum toxin or another named prescription drug. Work down in order — each step needs the one before it.

  1. Read carton and vialRecord brand, active ingredient, strength, lot, and expiration rather than a menu nickname.
  2. Confirm approvalSearch the exact drug in Drugs@FDA.Drugs@FDA (opens in a new tab) · U.S. Food & Drug Administration
  3. Read current labelingUse DailyMed for current package and prescribing information.DailyMed (opens in a new tab) · U.S. National Library of Medicine
  4. Confirm sourceAsk how the practice sourced the product and whether the manufacturer recognizes that supply channel.
  5. Verify injectorCheck the named injector against the issuing board; do not infer a credential from a website title.
  6. Name escalationGet the after-hours complication contact before the procedure, not after a problem occurs.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. Drugs@FDA: BLA 103000 (BOTOX, BOTOX COSMETIC) (opens in a new tab)FDA database
  2. DailyMed: BOTOX Cosmetic prescribing information (revised 10/2024) (opens in a new tab)Label
  3. FDA: Counterfeit Version of Botox Found in Multiple States (opens in a new tab)FDA notice

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

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