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FDA Recall & Compliance Alerts for Medspa Owners
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Compliance · Live FDA data

Aesthetic Safety Signals

Adverse-event report counts for the injectables, fillers, and devices you use — pulled from the FDA's FAERS (drugs) and MAUDE (devices) databases. 352,492 reports tracked across 15 products.

Read these carefully — they are signals, not verdicts. An adverse-event report does not prove the product caused the event. Counts are not adjusted for how widely a product is used, anyone can file a report, and totals reflect all reported history. Use this to know what to watch and ask about — not to rank products.
Neurotoxin

Botox

FAERS
76,811reports
20%serious
Most-reported reactions
Drug Ineffective 26,576
Off Label Use 11,500
Therapeutic Response Decreased 4,510
Headache 4,097
Product Preparation Error 3,647

Dysport

FAERS
6,881reports
30%serious
Most-reported reactions
Off Label Use 2,470
Drug Ineffective 1,812
Product Preparation Error 756
Headache 472
Muscular Weakness 384

Xeomin

FAERS
5,621reports
13%serious
Most-reported reactions
Drug Ineffective 1,836
Off Label Use 1,205
Therapeutic Response Decreased 733
Injection Site Pain 333
Product Preparation Issue 207

Jeuveau

FAERS
3,775reports
2%serious
Most-reported reactions
Drug Ineffective 1,589
Off Label Use 1,314
Therapeutic Product Effect Decreased 715
Drug Effect Less Than Expected 469
Headache 171

Daxxify

FAERS
68reports
32%serious
Most-reported reactions
Rash Papular 19
Drug Ineffective 11
Eyelid Ptosis 6
Headache 6
Anxiety 4
Dermal filler

Juvederm

MAUDE
9,642reports
87%serious

Sculptra

MAUDE
1,990reports
52%serious

Radiesse

MAUDE
1,628reports
75%serious

Restylane

MAUDE
1,206reports
80%serious
Energy device

CoolSculpting

MAUDE
11,096reports
98%serious

Morpheus8

MAUDE
62reports
100%serious

Ultherapy

MAUDE
42reports
93%serious

Emsculpt

MAUDE
6reports
83%serious
GLP-1 (weight-loss demand driver)

Tirzepatide (Mounjaro/Zepbound)

FAERS
160,663reports
18%serious
Most-reported reactions
Incorrect Dose Administered 29,672
Nausea 17,092
Injection Site Pain 13,906
Diarrhoea 10,006
Extra Dose Administered 9,608

Semaglutide (Wegovy/Ozempic)

FAERS
73,001reports
50%serious
Most-reported reactions
Nausea 10,674
Off Label Use 7,325
Vomiting 6,964
Diarrhoea 6,462
Decreased Appetite 4,905

When a safety signal turns into a recall, know first.

We watch these databases continuously. Inside MedSpa Pro flags the moment a product you use spikes, gets a warning, or hits a recall — and what to do about it.

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Source: openFDA FAERS & MAUDE. General information only — not medical, safety, or regulatory advice. Inside MedSpa is a general, impersonal publication for medical-aesthetics business owners. It is not individualized business, financial, medical, or legal advice. Any market or company information is general in nature and not a recommendation.

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