JUVEDERM VOLLURE XC 1ML SAMPLE 95661DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10840228302817), received between Apr 21, 2025 and Sep 15, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Off-Label Use” (5 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, 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient was injected 1ml in the lips with JUVÉDERM® VOLLURE¿ XC, "2 weeks after procedure patient presented with a non-inflammatory nodules, visible nodules, firm, palpable, no redness, no swelling, no pain". Treated with Clarithromycin 500 mg PO BIO X2 weeks and Hylenex. The event is ongoing.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50776102 ↗
• InjuryAug 7, 2026Off-Label Use

  Healthcare professional (HCP) reported injecting a patient with two syringes of JUVÉDERM VOLUMA® XC in the cheeks and one syringe of JUVÉDERM VOLLURE¿ XC off label in the neck. About ten months later, the patient experienced ¿one nodule under right eye and three nodules on neck. Patient was treated with Hylenex® and had a follow up appointment two weeks after. Symptoms status is unknown.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50176396 ↗
• InjuryAug 5, 2026Off-Label Use

  Healthcare professional reported injecting a patient in the lips with one syringe of JUVÉDERM VOLLURE¿ XC. A month later, the patient reported ¿blisters¿ on the lips, a ¿veiny¿ upper lip, and ¿nodules¿ and was treated that day with Valtrex 500 mg 1 per day for 10 days. Nine days later, the patient was treated with Clindamycin 200 mg 3 times per day for 10 days and a Medrol Dosepak. Six days later, the patient was given another Medrol Dosepak. Eight days later, a physical exam was performed, and the patient was advised to return in 4 weeks. Six weeks later, another physical exam was performed, with 90% of the event resolved. A month later, another physical exam was performed that showed ¿blisters (not open) and nodules.¿ The patient reported the lips looked fine for 8 days. Event was ongoing.

  Patient problems: Inflammation; Nodule

  MAUDE report 50148806 ↗
• InjuryJul 15, 2026Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 0.5 ML IN THE PRE-AURICULAR, CHEEKS WITH JUVÉDERM® VOLLURE¿ XC , "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Urinary Tract Infection

  MAUDE report 25828858 ↗
• InjuryJul 15, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 1.2 ML IN TEMPLES, CHEEKS, PRE AURICULAR AND LIPS WITH JUVÉDERM® VOLLURE¿ XC , "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Urinary Tract Infection

  MAUDE report 25828828 ↗
• InjuryJul 15, 2026Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 0.5 ML IN THE PRE-AURICULAR, CHEEKS WITH JUVÉDERM® VOLLURE¿ XC , "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Inflammation

  MAUDE report 25828801 ↗
• InjuryJul 15, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 1.2 ML IN TEMPLES, CHEEKS, PRE AURICULAR AND LIPS WITH JUVÉDERM® VOLLURE¿ XC , "PATIENT PRESENTED WITH A DELAYED INFLAMMATORY RESPONSE, HAD A UTI, LIPS ARE HARD AND SWOLLEN". LATER PHYSICIAN REPORTED " PATIENT STARTED EXPERIENCING SWELLING OF THE FILLER AND LATER PATIENT WAS DIAGNOSED WITH A UTI, FILLER IN LIPS WAS STILL FIRM ". STEROID INJECTION, MEDROL DOSE PACK, DOXYCYCLINE 100MG BID FOR 10 DAYS, AND NITROFURANTOIN 100MG BID X 5 DAYS WERE GIVEN AS TREATMENT. LATER PHYSICIAN REPORTED "MORE SWELLING IN LIPS AS WELL AS HARD BUMPS". LATER PHYSICIAN REPORTED "SWELLING GONE IN CHEEKS AND VERY MINIMAL IN THE LIPS". THE EVENT IS ONGOING.

  Patient problems: Inflammation; Nodule

  MAUDE report 25828780 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2 MLS OF JUVÉDERM® VOLUMA¿ XC INTO THE MIDFACE AND 1 ML OF JUVÉDERM® ULTRA PLUS XC INTO THE LIPS. PATIENT ALSO CONCOMITANTLY RECEIVED 1 ML OF VERSA IN THE LIPS. ABOUT 6 MONTHS LATER, PATIENT EXPERIENCED GENERALIZED SWELLING THROUGHOUT THE FACE AND WENT TO AN EMERGENCY ROOM WHERE A CT SCAN WAS CONDUCTED. PER THE EMERGENCY ROOM HEALTHCARE PROFESSIONAL, THE PRODUCT HAD MIGRATED. PATIENT WAS REFERRED BACK TO INJECTING HEALTHCARE PROFESSIONAL. EVENT IS ONGOING. INJECTING HEALTHCARE PROFESSIONAL HAS NOT PROVIDED TREATMENT AT THIS TIME.

  Patient problems: Inflammation

  MAUDE report 25348461 ↗
• InjuryMay 5, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LIPS WITH 1CC OF JUVÉDERM VOLLURE¿ XC. SIX DAYS POST INJECTION, PATIENT EXPERIENCED SWELLING AND NODULES. HCP LATER REPORTED PATIENT DENIES PAIN, DISCOLORATION, OR FEVER. HCP NOTED THEY HAVE RULED OUT VASCULAR OCCLUSION. HCP ADVISED PATIENT TO MASSAGE THE AFFECTED AREA ONCE DAILY. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. THE PACKAGED NEEDLE WAS USED.

  Patient problems: Nodule

  MAUDE report 25085985 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED IN THE LIPS WITH JUVÉDERM VOLBELLA® XC AND JUVÉDERM VOLLURE® XC. HCP LATER REPORTED THAT THE PATIENT WAS INJECTED IN FULLS LIPS WITH 0.9 CC JUVÉDERM VOLLURE® XC, THEN TWO WEEKS LATER, IN THE LIPS FOR TOUCHUP WITH 0.2 CC OF JUVÉDERM VOLBELLA® XC. THE PATIENT EXPERIENCED HARD, SWOLLEN, TENDER LIPS AT THE SITE OF INJECTION. AT FIRST IT WAS AT THE SITE OF THE JUVÉDERM VOLBELLA® XC INJECTIONS BUT THEN ALL THE SITES. THERE WAS MEDICAL INTERVENTION PROVIDED, PREDNISONE 60 MG TAPER (12 DAYS) + DOXYCYCLINE 100 MG BID (14 DAYS) PO, 2 UNITS OF HYLENEX IN THE LARGEST NODULE RIGHT UPPER CORNER LIP. 150 UNITS HDL C INDO/ EPI TOTAL TO DISSOLVE THE LIP FILLER. THE SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLLURE® XC.

  Patient problems: Nodule

  MAUDE report 21877564 ↗