JUVEDERM ULTRA PLUS XCRecalls & reported problems across all models

We found 2 models of JUVEDERM ULTRA PLUS XC by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 324 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2015 and Sep 14, 2026 — classified as 175 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (50 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 JUVEDERM ULTRA PLUS XC problems

JUVEDERM ULTRA PLUS XC models

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

• JUVEDERM ULTRA PLUS XC 94155

  Implant, Dermal, For Aesthetic Use
  319 reports
• JUVEDERM ULTRA PLUS XC 93900

  Implant, Dermal, For Aesthetic Use
  5 reports

Recent JUVEDERM ULTRA PLUS XC adverse event reports

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

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inflammation

  MAUDE report 50765390 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON-DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24865858 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24865840 ↗
• InjuryMar 16, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LIPS AND 0.2CC IN THE CHIN WITH JUVÉDERM® ULTRA PLUS XC. PATIENT EXPERIENCED A VASCULAR OCCLUSION "INTRAORALLY UNDER [THE] TONGUE". HCP NOTED THEY CHECKED ASPIRATION PRIOR TO EACH INJECTION. SYMPTOMS ARE ONGOING.

  Patient problems: Necrosis; Obstruction/Occlusion

  MAUDE report 24611493 ↗
• InjuryNov 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED PATIENT WAS TREATED WITH A TOPICAL RETINOID. PATIENT RECEIVED A V-BEAM TREATMENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23560747 ↗
• InjuryJul 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® ULTRA PLUS XC IN THE NASOLABIAL FOLD, PYRIFORM, AND LOWER CHEEK. HCP NOTICED THE PATIENT WAS EXPERIENCING VASCULAR OCCLUSION, "PALENESS AND BLANCHING OF SKIN AND STOPPED INJECTING". HCP TREATED THE PATIENT WITH 4ML OF HYALURONIDASE, MASSAGED THE SKIN, AND APPLIED HEAT. SYMPTOMS ARE ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22459816 ↗
• InjuryJun 23, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT INJECTED IN TEMPLES WITH 1ML PER SIDE JUVÉDERM® ULTRA PLUS XC AND IS STILL EXPERIENCING "SOME PAIN AND HAS SOME RESIDUAL FILLER", "HEADACHE ". TREATMENT INCLUDED TYLENOL , IBUPROFEN , DEXAMETHASONE, HYLENEX , GABAPENTIN , WARM COMPRESS, TOPICAL LIDO FOR PAIN RELIEF. ADDITIONALLY, PATIENT INFORMS THAT THE PAIN INS IMPACTING ITS QUALITY OF LIFE. SYMPTOMS NOT RESOLVED.

  Patient problems: Pain

  MAUDE report 22310095 ↗
• InjuryJun 7, 2025Off-Label Use; Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS UNEXPECTED ADVERSE DRUG EXPERIENCE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162857 ↗
• InjuryJun 7, 2025Off-Label Use; Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS INJURY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) ((B)(4)) AND (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162835 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED IN THE CHEEKS WITH 2CC OF JUVÉDERM® ULTRA PLUS XC. SIX DAYS LATER, THE PATIENTS "LEFT SIDE SALIVARY GLANDS BEGAN TO HURT, PAIN, SWOLLEN AND RIGHT-SIDE DENT [IN THE CHEEKS]". PATIENT REPORTED THEY HAVE BEEN PRESCRIBED ANTIBIOTICS BY URGENT CARE. INJECTING PHYSICIAN LATER REPORTED "PATIENT HAD A COINCIDENTAL PAROTITIS. THE INJECTION SITE WAS ABOUT 4-5 INCHES AWAY FROM THE SWELLING" AND STATED THE EVENT IS NOT DEVICE RELATED. SYMPTOMS RESOLVED ON AN UNKNOWN DATE.

  Patient problems: Salivary Gland Problem

  MAUDE report 21865456 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® ULTRA PLUS XC IN THE MARIONETTE LINES AND WITH 6 SYRINGES OF JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS/MIDFACE. THREE DAYS LATER, THE PATIENT EXPERIENCED AN ¿INFECTION¿ AND ¿REDNESS¿ ON THE CHIN, NEAR AN EXISTING CHIN IMPLANT. PRE TREATMENT INCLUDES CLEANING INJECTION WITH CHLORHEXIDINE. TWO DAYS LATER, THE PATIENT WAS TREATED WITH 210 UNITS OF HYLENEX. SYMPTOMS STATUS IS UNKNOWN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B)(6); (EMDR-76177). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM ULTRA PLUS XC.

  Patient problems: Unspecified Infection

  MAUDE report 21637660 ↗
• InjuryNov 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN THE LIPS WITH 1ML OF JUVÉDERM® ULTRA XC, IN THE LIPS WITH ONE SYRINGE JUVÉDERM® ULTRA PLUS XC. APPROXIMATELY TWO MONTHS LATER, PATIENT EXPERIENCED ¿LUMP AND SWELLING" ON THE UPPER LEFT-SIDE LIP WITH "DISCOMFORT, AND BURNING" IN THE LIPS AND HCP TREATED THE PATIENT WITH .01MLS OF HYLENEX®. APPROXIMATELY NINE MONTHS LATER, PATIENT WAS INJECTED WITH 0.5 ML IN LIPS AND 0.5ML IN CHEEKS OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED CENTRAL AREA OF "SLIGHT INFLAMMATION AND BRUISING¿. ON UNSPECIFIC TIME LATER, PATIENT WAS INJECTED IN THE LIPS WITH 0.25ML OF AN UNKNOWN JUVÉDERM PRODUCT. THE PATIENT EXPERIENCED ¿SMALL BUMP, PUSTULE, AND ULCERATION" TO THE UPPER LIP. EVENTS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00884 (ABBVIE COMPLAINT (B)(4), MDR ID# 3005113652-2023-00886 (ABBVIE COMPLAINT (B)(4), MDR ID# 3005113652-2023-00885 (ABBVIE COMPLAINT (B)(4). THIS MDR IS BEING SUBMITTED FOR THE 2ND SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Abscess; Nodule

  MAUDE report 18117193 ↗
• InjuryJul 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN THE LIPS WITH JUVÉDERM® ULTRA PLUS XC. A ¿LIP OCCLUSION¿ IN THE LOWER RIGHT SIDE OCCURRED. PATIENT WAS TREATED WITH 1500 UNITS OF HYALURONIDASE WERE PROVIDED 2 HOURS APART, TOTAL 300 UNITS. ¿BRUISING AND OCCLUSION¿ RESOLVED AFTER 24 HOURS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17415728 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN LIPS, PIRIFORM APERTURE MARIONETTE LINES. 1 DAY LATER, PATIENT WAS SEEN IN ER DUE TO A STROKE AND L HAND WEAKNESS FEET TINGLING ARM/LEGS. MRI RESULT WITH RESULTS OF TLA.

  Patient problems: Stroke/CVA

  MAUDE report 17326321 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED AROUND THE MOUTH WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC. UNSPECIFIC TIME LATER, PATIENT EXPERIENCED ¿RACING HEART AND HIGH BLOOD PRESSURE,¿ DEEMED NOT DEVICE RELATED. SYMPTOMS STATUS ARE UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 17318633 ↗

Other Allergan, Inc. products

• Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
• Natrelle INSPIRA Breast Implants197 models · 15,057 reports · 1 recall
• NATRELLE Saline-Filled Breast Implants103 models · 7,892 reports · 1 recall
• Natrelle Inspira SoftTouch Breast Implants195 models · 6,571 reports · 1 recall
• NATRELLE Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
• Natrelle Inspira Cohesive Breast Implants192 models · 2,949 reports · 1 recall
• JUVEDERM ULTRA XC3 models · 550 reports
• Natrelle 133S Tissue Expanders25 models · 319 reports