JUVEDERM ULTRA XCRecalls & reported problems across all models

We found 3 models of JUVEDERM ULTRA XC by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 550 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2014 and Aug 20, 2026 — classified as 145 injuries, 405 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (164 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 XC problems

JUVEDERM ULTRA XC models

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

• JUVEDERM ULTRA XC 94154

  Implant, Dermal, For Aesthetic Use
  541 reports
• JUVEDERM ULTRA XC 93899

  Implant, Dermal, For Aesthetic Use
  8 reports
• JUVEDERM ULTRA XC 96207

  Implant, Dermal, For Aesthetic Use
  1 report

Recent JUVEDERM ULTRA XC adverse event reports

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

• InjuryAug 20, 2026Improper or Incorrect Procedure or Method

  A healthcare professional reported that a patient was injected with 0.1mL of JUVÉDERM® Ultra XC In the lip. 2 hours later, the patient experienced swelling and blanching in the upper right lip quadrant. The patient was treated with 3 rounds of hylanex, aspirin, a heat pad, BBL C02, and hyperbaric chamber therapy. The event fully resolved after one week.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50349656 ↗
• InjuryJun 22, 2026Migration

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 1CC OF JUVÉDERM® ULTRA XC INTO THE NLFS AND THEN ROUGHLY TWO WEEKS LATER, PATIENT REPORTED THEY HAD A NODULE ON THE LEFT SIDE. UPON EXAMINATION OF PATIENT, IT WAS DETERMINED NOT TO BE A NODULE, RATHER A SLIGHT INDURATION LIKELY CAUSED BY FILLER MIGRATION. 15-20 UNITS OF HYLENEX WERE INJECTED INTO THE AREA AND PATIENT WAS MASSAGED. AREA WAS MUCH IMPROVED FOLLOWING THIS, BUT EVENTS STILL ONGOING.

  Patient problems: Inflammation

  MAUDE report 25579146 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED IN THE LIPS WITH JUVÉDERM® ULTRA XC. PATIENT EXPERIENCED BLISTERS IN THEIR MOUTH AND BOTTOM LIP "ALMOST IMMEDIATELY" POST INJECTION. PATIENT WAS TREATED WITH 2 ROUNDS OF ORAL ANTIVIRAL MEDICATION AND "DISSOLVER". SYMPTOMS ARE ONGOING.

  Patient problems: Blister

  MAUDE report 23030470 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® ULTRA XC IN THE NLF, 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE. 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) (B)(4) AND (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162864 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® ULTRA XC IN THE NLF, 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE. 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 XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162845 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 SYRINGE OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED ¿REDNESS, SWELLING ON FACE AND NECK, AND INCREASED TEMPERATURE" 2 DAYS LATER. TWO DAYS LATER, THE PATIENT PRESCRIBED PREDNISONE. EVENT STATUS IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 22108828 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED IN THE ¿GEL AREA DOWN BY THE CHIN¿ WITH 3 SYRINGES OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED ¿NUMBNESS AND TINGLING¿ THAT STOPPED 5 MONTHS LATER. THE PATIENT DESCRIBED IT AS ¿VERY PAINFUL¿ AND REPORTED BEING ¿DEPRESSED¿ FOR 2 MONTHS. THE FILLER WAS DISSOLVED BUT THE NUMBNESS REMAINED. THE PATIENT REPORTED THAT ANOTHER HEALTHCARE PROFESSIONAL THOUGHT IT MIGHT BE ¿PARTIAL VASCULAR OCCLUSION.¿ EVENT IS ONGOING.

  Patient problems: Depression

  MAUDE report 18119318 ↗
• 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# 3005113652-2023-00887 (ABBVIE COMPLAINT #(B)(4)), MDR ID# 3005113652-2023-00885 (ABBVIE COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE 3RD SUSPECT PRODUCT, JUVÉDERM® ULTRA XC.

  Patient problems: Abscess; Nodule

  MAUDE report 18117191 ↗
• InjuryOct 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH 1 ML OF JUVÉDERM® ULTRA XC INTO LIPS. 1 YEAR AND 4 MONTHS LATER, PATIENT WAS INJECTED AGAIN WITH 1 ML OF JUVÉDERM® ULTRA XC INTO LIPS. APPROXIMATELY 9 MONTHS FOLLOWING SECOND INJECTION, PATIENT NOTICED "LUMPS UNDERNEATH THE INSIDE OF THE LIP." HCP REPORTED LUMPS "LOOK LIKE SCALLOPED CURTAINS", "SETTLED INTO LIKE POCKETS", AND "FILLER COMES OUT WHEN PRESSING ON LUMPS." SYMPTOMS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID#3005113652-2023-00765 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF SUSPECT PRODUCT, JUVÉDERM® ULTRA XC.

  Patient problems: Skin Erosion

  MAUDE report 17878762 ↗
• InjuryAug 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM® ULTRA. THE LEFT SIDE OF THE LIP BEGAN ¿TURNING BLUE,¿ NOTING A ¿VASCULAR OCCLUSION.¿ THE INJECTION WAS STOPPED, AND THE PATIENT WAS TREATED WITH HYLENEX. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTING A PATIENT IN THE LEFT UPPER LIP AFTER APPLYING DENTAL BLOCKER FOR NUMBING AND .8 CC OF JUVÉDERM® ULTRA XC WERE INJECTED, THE PATIENT EXPERIENCED A ¿VASCULAR OCCLUSION¿ IN THE LIP. THE PATIENT WAS IMMEDIATELY TREATED WITH 150 U OF HYLENEX, HEAT WAS APPLIED, AND THE PATIENT WAS MASSAGED. THE PATIENT HAD SLIGHT IMPROVEMENT ALTHOUGH THERE WAS BRUISING, ¿POSSIBLY FROM THE AGGRESSIVE MASSAGING.¿ THE NEXT DAY, THE CAPILLARY REFILL OF THE PATIENT WAS STILL SLOW, SO ANOTHER 150 U OF HYLENEX WERE USED AND THE PATIENT WAS MASSAGED AGAIN. THE PATIENT WAS FOLLOWED UP FOR A WEEK. THE EVENT RESOLVED 11 DAYS POST-ONSET.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17638594 ↗
• InjuryJun 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED BLISTERS ON BOTTOM LIP AS WELL AS THE LEFT SIDE OF CHIN IS "PINKISH IN COLOR" AND HCP SUGGESTED IT IS A "VASCULAR OCCLUSION" AFTER THEY WERE INJECTED IN THE LIPS WITH 1 SYRINGE OF JUVÉDERM® ULTRA XC. TREATMENT IS NOTED AS ¿ASPIRIN AS WELL AS HYLENEX.¿ THE SYMPTOMS ARE ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17171296 ↗
• InjuryJun 7, 2023Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  PATIENT REPORTED THAT THEY WERE INJECTED IN THE NASOLABIAL FOLDS WITH 0.1 ML OF JUVÉDERM® ULTRA XC WITH A RE-USE OF THE SYRINGE. A FEW HOURS LATER, PATIENT EXPERIENCED PURPLE DOTS, PAIN, AND VASCULAR OCCLUSION TYPE SYMPTOMS ON THE UNDER LEFT EYE. THEIR NOSE HAD A BLUISH TONE ON THE LEFT SIDE. PATIENT WENT BACK TO THE OFFICE AND WAS TREATED WITH A WARM COMPRESS, 20 UNITS OF HYLENEX IN QUADRANT WHERE FILLER WAS INJECTED, AND ADVISED TO TAKE 300 MG OF ASPIRIN IN THE MORNING. THE PATIENT HAD TAKEN A TOTAL OF 650 MG OF ASPIRIN. ON THE NEXT DAY, PATIENT WAS DISSOLVED THE FILLER ON THE LEFT SIDE AND ALL SYMPTOMS RESOLVED IMMEDIATELY. LATER, HEALTHCARE PROFESSIONAL REPORTED 0.3 ML FILLER IN 3 AREAS OF FACE THEN HAD A BLUISH TINGED AREA 2 OF LEFT NOSTRIL THAT EXTENDED ACROSS THE BRIDGE OF NOSE TO JUST PAST MIDLINE CAP REFILL TO AREA L3 SEC. REPEATED HOT COMPRESSES AND INJECTED 20 UNITES HYLENEX (SUPER SITE) IN QUADRANT WHERE FILLER WAS INJECTED L OF L NOSTRIL IN THIS PATTERN AND THEN RESUMED HOT COMPRESSES TO AREA. PATIENT WAS INJECTED WITH THE ENTIRE VIAL OF HYLENEX 150 USP/ML ACROSS ENTIRE INJECTION AREA L OF L NOSTRIL. RESUMED HOT COMPRESS WITH PINKNESS HAD RETURNED TO NOSE AND CAP REFIL

  Patient problems: Obstruction/Occlusion

  MAUDE report 17083934 ↗
• InjuryJun 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LOWER LIP WITH 0.4 CC OF JUVÉDERM® ULTRA. THE PATIENT IMMEDIATELY EXPERIENCED AN ¿OCCLUSION.¿ THE PATIENT WAS TREATED WITH 24 ML OF HYLENEX AND HYPERBARIC, AND THE HEALTHCARE PROFESSIONAL BELIEVES THAT THEY WERE ABLE TO CANNULATE THE ARTERY WITH AN ULTRASOUND. THE PATIENT HAS A SMALL AMOUNT OF CAPILLARY REFILL. THE EVENT IS ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17067135 ↗
• InjuryMar 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH JUVÉDERM VOLUMA® XC IN THEIR CHEEKS AND CHIN. TWO WEEKS LATER, PATIENT WAS INJECTED WITH 1 SYRINGE OF JUVÉDERM® ULTRA XC IN THEIR LIPS. ON THE SAME DAY, THE PATIENT EXPERIENCED POSSIBLE VASCULAR OCCLUSION AND SLIGHTLY SLOWER CAPILLARY REFILL. THE PATIENT WAS MASSAGED AND GIVEN 30 U OF HYLENEX, FOLLOWED BY AND 200 U OF HYLENEX THE NEXT DAY. THE EVENT RESOLVED WITH TISSUE A LITTLE SLOWER TO REFILL IN LESS THAN 3 SECONDS AND THE ORAL MUCOSA AND SURROUNDING TISSUE BECOMING PINK AGAIN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16553116 ↗
• InjuryJan 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH .3 CC OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED ¿VASCULAR OCCLUSION¿ AT THE INJECTION SITE THAT DAY. THREE DAYS LATER, THE PATIENT WAS TREATED AT ANOTHER OFFICE WITH HYLENEX, ANTIBIOTICS, PREDNISONE, AND VALTREX. AN ULTRASOUND WAS PERFORMED BY A DIFFERENT HEALTHCARE PROFESSIONAL, AND THE RESULTS NOTED AS ¿DARK AREA AROUND LATERAL ASPECT OF SLI WHICH APPEARED COMPRESSED BY HYALURONIC ACID. INFERIOR ASPECT OF COLUMELLAR ARTERY THAT MEETS AT TOP OF PATIENT¿S GK POINT ALSO DARK.¿ ANOTHER ULTRASOUND WAS PERFORMED THE NEXT DAY WITH THE RESULTS NOTED AS ¿ULTRASOUND: MEDIAL PORTION OF UPPER LIP, AT THE GK POINT AND THE PHILTRAL COLUMN SLUGGISH. CAP REFILL. COLOR DOPLER SHOWED PERFUSION OF VESSELS ¿ SEPTAL BRANCH AND COLUMELLAR BRANCH.¿ THE EVENT RESOLVED 3 DAYS LATER, BUT AFTER 5 DAYS, THE PATIENT WAS STARTED ON CUTAGENIX TOPICAL AND A TOTAL OF 1800 UNITS OF HYLENEX AND 1500 OF HYALURONIDASE. THE EVENT IMPROVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16137497 ↗

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