JUVEDERM VOLUX XC 1ML SAMPLE 20074128Recalls & reported problems
Allergan, Inc. · JUVEDERM VOLUX XC 1ML SAMPLE · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10840228302831), received between May 12, 2026 and Sep 14, 2026 — classified as 7 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- Abscess2
- Inflammation2
- Bacterial Infection1
- Medical Device Site Inflammation1
- Nodule1
- Subcutaneous Nodule1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional (HCP) reported injecting a patient with JUVÉDERM VOLUX¿ XC in the jawline area. About a week and a half later, the patient ¿reported redness and irritation in the area of injection.¿ After discussion, the patient did say that they applied topical skincare products to the face shortly after being injected. They also had a deep teeth cleaning 2 days after the filler injection. The patient was treated with Hylanex ® twice three days apart. The patient was also given antibiotics. The area of redness and irritation has been showing improvement. Symptoms are ongoing.
Patient problems: Inflammation
MAUDE report 50756146 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported a patient who was injected with 7 mL of JUVÉDERM® VOLUMA¿ XC in the cheek area. The patient was also injected with 2 mL of JUVÉDERM® VOLUX¿ XC in the cheek and injection sites and jawline at gonial angle 0.5 ml per side. Post injection the patient contacted the HCP regarding the right side between their lips and chin that was very sore after the injection. The HCP reassured the patient that it was likely filler, and it needed to settle. The HCP instructed them not to press or manipulate the filler and that it could take few weeks to settle. Recently the lump on the right side of their chin is now swollen and painful. The HCP requested the patient come for a visit. The HCP prescribed the patient doxycycline for upper respiratory infection. Also were treated with doxycycline which they prescribed for seven days and prescribed the patient to take more Prednisone 60mg for 3 days, 40mg for 3 days, 20 mg for 3 days and 10 mg for 3 days.
Patient problems: Bacterial Infection
MAUDE report 50116902 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported a patient who was injected with 7 mL of JUVÉDERM® VOLUMA¿ XC in the cheek area. The patient was also injected with 2 mL of JUVÉDERM® VOLUX¿ XC in the cheek and injection sites and jawline at gonial angle 0.5 ml per side. Post injection the patient contacted the HCP regarding the right side between their lips and chin that was very sore after the injection. The HCP reassured the patient that it was likely filler, and it needed to settle. The HCP instructed them not to press or manipulate the filler and that it could take few weeks to settle. Recently the lump on the right side of their chin is now swollen and painful. The HCP requested the patient come for a visit. The HCP prescribed the patient doxycycline for upper respiratory infection. Also were treated with doxycycline which they prescribed for seven days and prescribed the patient to take more Prednisone 60mg for 3 days, 40mg for 3 days, 20 mg for 3 days and 10 mg for 3 days.
Patient problems: Nodule
MAUDE report 50116891 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported that a patient was injected into the chin using an unknown JUVÉDERM® VOLUX¿ XC. 3 to 4 weeks after the injection the patient started to feel tender in the chin. The chin became very swollen, and the healthcare professional was concerned about a potential abscess. The patient was referred out to a dermatologist who performed an incision and drainage, then used a pressure bandage. There was a lot of puss drained, it had cultured, and the patient is currently on 2 antibiotics.
Patient problems: Abscess
MAUDE report 50071517 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED THEY INJECTED WITH 0.8 MLS OF JUVÉDERM® VOLUX¿ XC INTO A PATIENT'S JAWLINE THREE TO FOUR MONTHS LATER, NODULES WERE EXPERIENCED. ONE ON EACH SIDE WAS NOTED WITH ONE BEING MORE VISIBLE AND ONE BEING LESS VISIBLE. HEALTHCARE PROFESSIONAL DISSOLVED THE PRODUCT AND EVENT RESOLVED.
Patient problems: Subcutaneous Nodule
MAUDE report 25636839 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 2 SYRINGES OF JUVÉDERM VOLUX¿ XC IN THE LEFT CHEEK, MARIONETTE LINES, ZYGOMA, AND RIGHT CHEEK INDENTATION. THE PATIENT CONCOMITANTLY TAKES ¿LAMTETAC 400 AND COPAZLAM 15Q.¿ TWO WEEKS POST INJECTIONS, THE PATIENT EXPERIENCED ¿SWELLING, HOT TO TOUCH, PATIENT¿S BODY IS REJECTING THE PRODUCT IN THE CHEEKS. THAT SAME DAY THE PATIENT HAD A ¿BACTERIA CULTURE¿ PERFORMED, WHICH WAS NEGATIVE. ALSO, THAT SAME DAY, THE PATIENT WAS TREATED WITH BACTRIM. TWO DAYS LATER, THE PATIENT WAS ALSO TREATED WITH HYLENEX®. THE HCP ADDITIONALLY REPORTED "PATIENT DEVELOPED STERILE ABSCESS ONLY WHERE THE SYRINGE INJECTED ON THE LEFT SIDE OF THE FACE. SIGNIFICANT AMOUNT OF PURULENT XXXX DRAINED AND STILL IS XXX.¿ SYMPTOMS ARE ONGOING.
Patient problems: Abscess; Medical Device Site Inflammation
MAUDE report 25437198 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED INTO THE JAWLINE WITH 1CC OF JUVÉDERM® VOLUX¿ XC A WEEK LATER THE PATIENT WAS PRESENTED WITH RIGHT CHIN REDNESS, SWOLLEN, TENDERNESS AND IT WAS WARM TO THE TOUCH. SINCE THE PATIENT IS ALSO A HEALTHCARE PROFESSIONAL, THEY PRESCRIBED THEMSELVES AUGMENTIN AND PREDNISONE WHEN THE SYMPTOMS 1ST APPEARED. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED THAT A PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® VOLUX¿ XC INTO THE SUPRA PERIOSTEUM. THE PATIENT DEVELOPED ERYTHEMA AND 2 INDURATION AND WARM TO TOUCH NOTED TO DEPOSIT SITE OF FILLER ON THE RIGHT LATERAL MENTOM. THE HCP STATED THAT THERE IS A DIFFERENTIAL BY ACUTE INFECTION VS. EARLY ONSET INFLAMMATORY REACTION. THE PATIENT SELF-PRESCRIBED THEMSELVES OF AUGMENTIN AND PREDNISONE. ALSO, THE HCP PROVIDED RX FOR CLARITHROMYCIN 500 MG, BID FOR 2 WEEKS. THE SYMPTOMS HAVE NOT BEEN FULLY RESOLVED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25150852 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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