JUVÉDERM VOLBELLA XCRecalls & reported problems across all models

We found 3 models of JUVÉDERM VOLBELLA XC by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 278 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 28, 2026 — classified as 240 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported JUVÉDERM VOLBELLA XC problems

JUVÉDERM VOLBELLA XC models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• JUVÉDERM VOLBELLA XC 95834

  Implant, Dermal, For Aesthetic Use
  187 reports
• JUVÉDERM VOLBELLA XC 96181

  Implant, Dermal, For Aesthetic Use
  60 reports
• JUVÉDERM VOLBELLA XC 96183

  Implant, Dermal, For Aesthetic Use
  31 reports

Recent JUVÉDERM VOLBELLA XC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Subcutaneous Nodule

  MAUDE report 50924567 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported a patient was injected with 1ml of JUVÉDERM VOLUMA® XC into the cheek and 1ml of JUVÉDERM VOLBELLA® XC. Botox was also injected. Patient later experienced an allergic reaction that made them itchy all over their body. Patient called an ambulance two days after injection. Patient also went to see their primary care physician two days later and was prescribed antibiotics and steroids. Event ongoing.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50264947 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported injecting a patient in the lips, oral commissures, perioral, and rhytids with 1 syringe syringes of JUVÉDERM® VOLBELLA¿ XC. Two months later, the patient had a dental cleaning and experienced ¿3 non-inflammatory nodules/bumps¿ later that month in the upper lip that were found via an early manual palpation. The same day as the palpation exam, the patient was on Zyrtec and had Pepcid added. Two and a half weeks later, the patient was treated with Ibuprofen 400 mg TID PO and Hyaluronidase with additional Hyaluronidase given 3 days later. Two weeks later, the patient the patient was examined again, where the number of nodules was found to have increased (7 in the upper lip and 6 in the lower lip), and the patient was treated with Doxycycline and a Medrol Dosepak that were started 3 days later. Event was ongoing.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50194629 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient was injected 2 ml with JUVÉDERM® VOLBELLA¿ XC, "Account needs to report an adverse event". Later physician reported "Hard nodule and erythema". Treated with Doxycycline 100 mg BID for 14 days, Clarithromycin 500mg BID for 28 days, Prednisone 40mg for 15 days. The event is ongoing.

  Patient problems: Nodule

  MAUDE report 50181121 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060755 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060705 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported being injected with an unspecified JUVÉDERM®. The next year, the patient experienced ¿bumps¿ all over the face, under the lips, and sides of the cheeks¿ that were described as ¿pretty thick¿ on the upper lip, some on the jawline, and on the cheekbone, the size of ¿maybe a dime or nickel.¿ A CT scan confirmed the nodules. The patient as treated with Amoxicillin that they had just completed, and steroids were considered next. The filler looked like it was ¿protruding out the sides of the face.¿ Event was ongoing.Additionally, the healthcare professional reported that the patient was injected in the cheek, lips, and jawline with 1 cc of JUVÉDERM® VOLUMA¿ XC, 1 cc of JUVÉDERM® VOLBELLA¿ XC, and 1 cc of JUVÉDERM® VOLUX¿ XC. The event occurred at the injection sites. The Amoxicillin treatment was not given by the injector, and no specifics could be given for it. Two months post-onset, the patient was treated with Keflex 500 mg PO BID. Two weeks later, the patient was treated with a Medrol Dosepak to be taken as directed and Hylenex.This file captured the JUVÉDERM® VOLBELLA¿ XC.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50009089 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE CHIN (MENTUM) WITH 1ML OF JUVÉDERM® VOLUMA® XC. FOUR MONTHS POST-INJECTION PATIENT RETURNED TO THE INJECTING CLINIC EXPERIENCING "PALPABLE NODULES IN THE MENTUM, CLINICALLY SUGGESTIVE OF PRODUCT MIGRATION". ON THE SAME DAY, PATIENT WAS TREATED WITH 1 VIAL HYLENEX, RECONSTITUTED WITH 0.2ML SODIUM BICARBONATE AND 0.2ML OF 2% LIDOCAINE. DURING THE TREATMENT APPOINTMENT PATIENT WAS ALSO INJECTED WITH 0.5ML OF JUVÉDERM® VOLBELLA® XC TO THE UPPER LIP. ONE MONTH LATER, PATIENT REPORTED "INTERMITTENT SWELLING OF THE BILATERAL JAWLINE AND CHIN SINCE TREATMENT. SWELLING IS FLUCTUATING, WITH EPISODES OF RESOLUTION AND RECURRENCE". PATIENT ALSO EXPERIENCED "EPISODIC SWELLING OF BOTH UPPER AND LOWER LIPS, DESCRIBED AS FIRM WHEN PRESENT. NO SWELLING OR FIRMNESS OBSERVED ON EXAM". HCP NOTED THEIR CLINICAL FINDS AS THE "CHIN APPEARS TIGHT, FIRM, AND SOMEWHAT RIGID IN CONTOUR", THE "RIGHT JAWLINE/JOWL DEMONSTRATES FULLNESS CONSISTENT WITH POSSIBLE PRODUCT MIGRATION", AND THE "LEFT JAWLINE/JOWL WITHOUT PALPABLE FIRMNESS OR VISIBLE SWELLING ON EXAM, THOUGH PATIENT REPORTS INTERMITTENT SYMPTOMS OF EPISODIC SWELLING AND FIRMNESS". PATIEN

  Patient problems: Inflammation

  MAUDE report 24969415 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH JUVÉDERM VOLUMA® XC. TEN MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLLURE¿ XC. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLBELLA® XC. HCP REPORTED THE PATIENT WAS EXPERIENCING "HYPERSENSITIVITY". HCP LATER REPORTED PATIENT WAS EXPERIENCING DELAYED ONSET NODULES IN THE LIPS, NASOLABIAL FOLDS, CHEEKS, AND MARIONETTE LINES. SYMPTOMS BEGAN 6 DAYS POST A MICRO NEEDLING SESSION WITH PLATED EXOSOMES. PATIENT WAS TREATED WITH 2 DISSOLUTION TREATMENTS 12 DAYS APART. HCP LATER REPORTED PATIENT HAD "PERIORBITAL EDEMA DURING FLARE". PATIENT VISITED URGENT CARE AND HAD BLOODWORK DONE WHICH DID NOT SHOW AN INFECTION. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. THE PACKAGED NEEDLE WAS USED. THIS RELATES TO JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 24957788 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  HCP REPORTED THE PATIENT RECEIVED HALF A SYRINGE OF JUVÉDERM® VOLBELLA® XC SIX MONTHS PRIOR WITH NO ADVERSE EVENT.

  Patient problems: Nodule

  MAUDE report 24593091 ↗
• InjuryMar 10, 2026Migration

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT INJECTED IN THE LIPS WITH 1ML OF JUVÉDERM® VOLBELLA¿ XC, IN THE SMILE LINE WITH 1ML OF JUVÉDERM® VOLLURE¿ XC AND IN THE JAWLINE, CHECKS AND PREJOWL SULCUS WITH 1ML OF JUVÉDERM® VOLUMA¿ XC PRESENT "DELAYED ONSET NODULES AFFECTING RIGHT LOWER LIP, AND BILATERAL JAWLINE". LATER HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY A MONTH AFTER INJECTION PATIENT HAD A LIP TOUCH UP WITH 1 ML OF JUVÉDERM® VOLBELLA¿ XC AND APPROXIMATELY THREE MOUNTS AFTER ORIGINAL INJECTION "PATIENT NOTICED SWELLING OF THE RIGHT SIDE LOWER LIP" AND SIX DAYS LATER "LEFT SIDED JAWLINE INFLAMMATION" AND THEN "SWELLING PROGRESSED TO THE RIGHT SIDE OF THE JAWLINE WITH NODULE FORMATION", HEALTHCARE PROFESSIONAL ALSO INDICATE "BILATERAL JAWLINE SWELLING WITH NODULE FORMATION AND LOWER LIP SWELLING WITH NODULE FORMATION" AND "INFLAMMATION OF LIPS AND FILLER MIGRATION". LATER HEALTHCARE PROFESSIONAL REPORTED THAT FILLER MIGRATION WAS JUST IN LIPS. PATIENT WAS PRETREATMENT WITH TOPICAL OINTMENT NAXEXIS OINTMENT AND POSTTREATMENT WITH ICE AND FOR THE SYMPTOMS PATIENT WAS TREATMENT WITH DOXYCYCLINE 100MG TWICE A DAY FOR 14DAYS. PATIENT REPORT SIGNIFICANT REDUCTION IN NODULES. EVEN

  Patient problems: Nodule

  MAUDE report 24562241 ↗
• InjuryMar 4, 2026Migration

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT INJECTED IN THE LIPS WITH 1ML OF JUVÉDERM® VOLBELLA¿ XC, IN THE SMILE LINE WITH 1ML OF JUVÉDERM®VOLLURE¿ XC AND IN THE JAWLINE, CHECKS AND PREJOWL SULCUS WITH 1ML OF JUVÉDERM® VOLUMA¿ XC PRESENT "DELAYED ONSET NODULES AFFECTING RIGHT LOWER LIP, AND BILATERAL JAWLINE". LATER HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY TWO MONTHS AFTER INJECTION PATIENT HAD A LIP TOUCH UP AND "PATIENT NOTICED SWELLING OF THE RIGHT SIDE LOWER LIP" AND SIX DAYS LATER "LEFT SIDED JAWLINE INFLAMMATION" AND THEN "SWELLING PROGRESSED TO THE RIGHT SIDE OF THE JAWLINE WITH NODULE FORMATION", HEALTHCARE PROFESSIONAL ALSO INDICATE "BILATERAL JAWLINE SWELLING WITH NODULE FORMATION AND LOWER LIP SWELLING WITH NODULE FORMATION" AND "INFLAMMATION OF LIPS AND FILLER MIGRATION". PATIENT WAS PRETREATMENT WITH TOPICAL OINTMENT NAXEXIS OINTMENT AND POSTTREATMENT WITH ICE AND FOR THE SYMPTOMS PATIENT WAS TREATMENT WITH DOXYCYCLINE 100MG TWICE A DAY FOR 14DAYS. EVENT IS ONGOING. THIS RECORD IS FOR THE PRODUCT JUVÉDERM® VOLBELLA¿ XC.

  Patient problems: Nodule

  MAUDE report 24513776 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT EXPERIENCED SWELLING AND LATE ONSET NODULE 6 MONTHS POST-INJECTION IN THE UPPER AND LOWER LIPS. PATIENT VISITED URGENT CARE WHERE THEY RECEIVED AN EKG AND BLOOD WORK WITH NEGATIVE TEST RESULTS. PATIENT RECEIVED PREDNISONE AT URGENT CARE. PATIENT WAS TREATED WITH 0.3CC OF HYALURONIDASE. SYMPTOMS RESOLVED AN UNKNOWN AMOUNT OF TIME AFTER INJECTION.

  Patient problems: Nodule

  MAUDE report 24248441 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 5 SYRINGES OF JUVÉDERM® VOLUMA¿ XC INTO THE CHEEKS AND TEMPLES. PATIENT RETURNED THE FOLLOWING DAY AND WAS INJECTED WITH BOTOX. THE HEALTHCARE PROFESSIONAL NOTICED THAT PATIENT HAD MINIMAL SWELLING TO THE FACE, BUT "ALL WITHIN PARAMETERS 24 HOURS POST FILLER INJECTION." A LITTLE OVER TWO WEEKS LATER, PATIENT RETURNED WITH NO CONCERNS AND WAS INJECTED WITH 1ML OF JUVÉDERM® VOLUMA¿ XC INTO THE CHEEKS AND 0.55MLS OF JUVÉDERM® VOLBELLA¿ XC INTO THE LIPS. ABOUT THREE WEEKS LATER, PATIENT HAD SWELLING IN THE LEFT CHEEK AND WAS ADVISED TO TAKE ZYRTEC. SWELLING RESOLVED. A WEEK LATER, PATIENT EXPERIENCED RIGHT CHEEK SWELLING AND A MEDROL DOSE PACK WAS STARTED. TWO DAYS LATER, THE SWELLING WAS BETTER BUT A "BUMP" BELOW THE LEFT EYE AND UPPER LIP WAS NOTED. SWELLING RETURNED 5 DAYS LATER AND ANOTHER MEDROL DOSE PACK WAS STARTED. THE SWELLING IMPROVED THE FOLLOWING DAY BUT THE BUMPS REMAINED PRESENT. 5 DAYS LATER, PATIENT WAS SEEN IN PRACTICE WITH NO SWELLING. MASSAGE AND DIRECT PRESSURE WERE APPLIED TO THE BUMPS AND THEY WERE MUCH IMPROVED. SWELLING RETURNED TWO DAYS LATER GENERALIZED IN THE CHEEKS. PREDNISONE 5MG WAS STARTED FOR 3

  Patient problems: Inflammation

  MAUDE report 24056424 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED WITH 0.5 ML OF JUVÉDERM® VOLBELLA¿ XC IN THE VERMILION LIPS. TWO MONTHS LATER, PATIENT WAS INJECTED WITH 0.3 ML OF JUVÉDERM® VOLBELLA¿ XC IN THE LIPS. TWO MONTHS LATER, PATIENT WAS INJECTED WITH 1 ML OF JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS. TWO WEEKS LATER, PATIENT DEVELOPED 3 LUMPS INSIDE BOTTOM LIP AND 1 TOP RIGHT UPPER LIP AT CUPID'S BOW WITH BURNING SENSATION AND SWELLINGS. PATIENT FELT RUN DOWN WITHOUT FEVER. THE PATIENT WAS TREATED WITH STEROIDS AND VALTREX. TWO MONTHS LATER, PATIENT WAS TREATED WITH 3 ROUNDS PO STEROIDS, VALTREX, ANTIHISTAMINE, 0.2 ML OF HYLENEX, AND R/U LISINOPRIL REACTION AS CULPRIT OF ORAL SWELLING. SYMPTOMS RESOLVED APPROXIMATELY 3 MONTHS AFTER ONSET. THIS RECORD IS FOR THE 1ST INJECTION OF JUVÉDERM® VOLBELLA¿ XC.

  Patient problems: Nodule

  MAUDE report 23733377 ↗

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