Key takeaways
- FDA warned on April 16, 2024 that counterfeit Botox had been found in multiple states and given for cosmetic purposes.
- The 2024 fakes carried lot number C3709C3, "Botulinum Toxin Type A" as the ingredient and a 150-unit vial size AbbVie and Allergan do not make.
- Packaging that looks clean is not proof: confirm the product comes from an authorized source and the injector is licensed and trained.
- The Allē directory signals authorized sourcing, but Allergan does not verify the credentials listed there.
- Vision changes, drooping eyelids, or trouble swallowing or breathing after an injection mean contacting a health care professional or going to the emergency room.
What counterfeit Botox is and where it comes from
Botox is the brand name for onabotulinumtoxinA, a prescription medicine, and AmSpa's position is that injecting it is the practice of medicine precisely because a prescription drug is being used on living tissue.
A counterfeit version is a fake product made to pass as that drug: FDA warned in 2024 that unsafe counterfeit Botox had been found in multiple states and administered to consumers for cosmetic purposes.
FDA said the incidents occurred when the product was injected by licensed and unlicensed individuals and/or in non-medical or unlicensed settings, and that the products appear to have been purchased from unlicensed sources.
So the authenticity question starts with the supply chain, not the brand name on the menu: federal law requires providers to buy prescription drugs only from authorized sources.
2024 CDC and FDA warnings: what happened
On April 16, 2024, FDA warned that unsafe counterfeit versions of Botox had been found in multiple states and administered to consumers for cosmetic purposes, causing adverse events including hospitalizations.
FDA's symptom list at the time included blurred or double vision, difficulty swallowing, dry mouth, shortness of breath, weakness and difficulty lifting the head.
The CDC's investigation, closed with a final update on June 24, 2024, counted 17 people in 9 states with harmful reactions between November 4, 2023 and April 11, 2024, after injections with counterfeit products, products from unverified sources, or from individuals who were not following state or local requirements.
Thirteen of the 17 (76%) were hospitalized and 6 (35%) received botulism antitoxin; all were female, aged 25 to 67, with a median age of 43.
FDA said there was no indication the events were linked to genuine AbbVie Botox.
Signs your product may be fake
FDA's 2024 advisory described specific markings on the counterfeit product it found:
- Lot number C3709C3 on both the outer carton and the vial.
- The active ingredient shown as "Botulinum Toxin Type A" instead of onabotulinumtoxinA.
- A 150-unit vial — a size AbbVie and Allergan do not make.
- Text in a language other than English on the carton.
Genuine Botox Cosmetic comes in 50-unit and 100-unit vials; therapeutic Botox comes in 100-unit and 200-unit vials.
Those signs describe the specific counterfeit lot FDA identified in 2024, so packaging that looks clean is not proof of a genuine product.
Genuine Botox Cosmetic vs the 2024 counterfeit
| Marking | Genuine Botox Cosmetic | 2024 counterfeit (FDA) |
|---|---|---|
| Active ingredient | OnabotulinumtoxinA | "Botulinum Toxin Type A" |
| Vial size | 50 or 100 units | 150 units |
Is diluted Botox a thing? Units vs reconstitution
Dilution is a labeled step, not a hack: the Botox Cosmetic label calls for reconstitution with preservative-free saline.
The labeled concentration is 4 units per 0.1 mL, the label says to refrigerate the mixed product and use it within 24 hours, and any remainder is discarded.
The number of units in a vial is set by the manufacturer — Botox Cosmetic comes in single-dose 50-unit and 100-unit vials — and reconstitution changes the concentration, not that count.
Units are also product-specific: the label states that Botox Cosmetic's units cannot be compared to or converted into units of any other botulinum toxin product.
What about the story that a clinic stretches a vial with extra saline?
We could not confirm any FDA or CDC finding of that: the 2024 investigations described counterfeit products, products from unverified sources, or providers not following state or local requirements.
If you want to know what you received, ask your provider how many units were injected and where the product was purchased — the same confirm-it-with-your-provider check FDA recommends on sourcing.
How to verify: ask to see the box, check the Allē directory
FDA advises consumers to confirm with their provider that the product comes from an authorized source and to ask whether the provider is licensed and trained to give the injection.
For fillers, FDA's consumer guidance says the same in product terms: choose a licensed provider experienced in dermatology or plastic surgery and trained to inject, who uses properly labeled, sealed vials or pre-filled syringes of FDA-approved filler.
- Ask which product you are getting and whether it was bought from an authorized source.
- Ask to see the sealed carton and vial before the injection: genuine Botox Cosmetic is a single-dose 50-unit or 100-unit vial that names onabotulinumtoxinA as the ingredient.
- Ask whether the injector is licensed and trained to inject botulinum toxin.
- Check credentials yourself: nurse licenses through NCSBN's Nursys QuickConfirm lookup, and ABMS board certification free at CertificationMatters.org.
If you use Allergan's Allē program, you can also check the Allē provider directory.
Allergan says the directory lists providers that buy Allergan Aesthetics products from authorized, legitimate sources; all other directory information, including credentials, is entered by the provider and is not verified by Allergan.
Symptoms that need urgent care
CDC's symptom list from the 2023–2024 counterfeit botulinum toxin cases: blurry and double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue and generalized weakness.
FDA's advice: anyone who has these symptoms after a botulinum toxin injection should contact a health care professional or go to the emergency room.
FDA asks consumers to report suspected counterfeit products to the agency at 800-551-3989; adverse events can be reported through FDA's MedWatch program.
CDC's list, 2023–2024 cases
- Blurry and double vision
- Drooping eyelids
- Difficulty swallowing
- Dry mouth
- Slurred speech
- Difficulty breathing
- Fatigue and generalized weakness
FDA's list, April 2024 warning
- Blurred or double vision
- Difficulty swallowing
- Dry mouth
- Shortness of breath
- Weakness
- Difficulty lifting the head
For what to do after any treatment goes wrong — what to document, who to contact and when — see what to do if something goes wrong.
Every US botulinum toxin label carries a boxed warning that the toxin's effects may spread beyond the injection area — generalized weakness, double vision, drooping eyelids, swallowing or breathing difficulty — reported hours to weeks after injection. The label's own words: swallowing and breathing difficulties can be life threatening and there have been reports of death.
Find verified providers near you
Who may inject botulinum toxin varies by state: AmSpa says injecting it is the practice of medicine, so it must be done by a physician, an independent-practice nurse practitioner, or another licensed professional acting within their scope, under rules that vary by state.
License lookups, the carton-and-vial check and the Allē directory signal are all things you can do before you book, not after.
CDC's bottom line for consumers: only get botulinum toxin injections if the product comes from an authorized supplier and the provider is licensed and trained to give the injection.
In CDC's words, "If in doubt, don't get the injection."
Frequently asked questions
How can I tell if my Botox is fake?
FDA's 2024 advisory described counterfeit Botox with lot number C3709C3 on the carton and vial, an ingredient label reading "Botulinum Toxin Type A" instead of onabotulinumtoxinA, a 150-unit vial — genuine Botox Cosmetic comes in 50- and 100-unit vials — and non-English carton text.
Packaging alone is not proof either way, so FDA's core advice is to confirm with your provider that the product comes from an authorized source.
What are the symptoms of counterfeit Botox?
CDC listed blurry and double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue and generalized weakness in the 2023–2024 cases.
FDA advises anyone who has these symptoms after a botulinum toxin injection to contact a health care professional or go to the emergency room.
Botulinum toxin labels also warn that toxin effects can spread beyond the injection area, reported hours to weeks after injection.
What was the 2024 counterfeit Botox outbreak?
On April 16, 2024, FDA warned that counterfeit Botox had been found in multiple states and given for cosmetic purposes, causing adverse events including hospitalizations.
CDC's closed investigation counted 17 people in 9 states with harmful reactions between November 4, 2023 and April 11, 2024, after injections with counterfeit products, products from unverified sources, or from individuals not following state or local requirements; 13 (76%) were hospitalized and 6 (35%) received botulism antitoxin.
All were female, aged 25 to 67.
Is my Botox diluted?
Reconstitution is part of how Botox is given: the label calls for the drug to be reconstituted with preservative-free saline to 4 units per 0.1 mL and used within 24 hours.
We found no FDA or CDC finding that Botox had been watered down with extra saline in the 2024 cases, which involved counterfeit products, products from unverified sources, or providers not following state or local requirements.
Does the Allē directory verify injector credentials?
No. Allergan says the Allē provider directory lists providers that buy Allergan Aesthetics products from authorized, legitimate sources; all other information on a listing, including credentials, is entered by the provider and is not verified by Allergan.
Treat the directory as a signal that product is sourced through authorized channels, and check licenses separately through national and state databases.
Sources
Every number on this page comes from one of these sources and was checked against it.
- alle.com · alle.com
- Counterfeit Version of Botox Found in Multiple States · U.S. Food and Drug Administration
- cdc.gov · CDC
- Dermal Filler Do's and Don'ts for Wrinkles, Lips and More · U.S. Food and Drug Administration
- Certification Matters · certificationmatters.org
- nursys.com · nursys.com
- What Are the Rules for Who Can Inject Neurotoxins? · American Med Spa Association
- BOTOX COSMETIC- onabotulinumtoxina injection, powder, lyophilized, for solution · DailyMed, U.S. National Library of Medicine
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.