Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action.

Aptryxol (desvenlafaxine)

DaTscan (ioflupane I 123 injection)

Desvenlafaxine extended-release tablets

Effexor XR (venlafaxine extended-release) capsules

Pristiq (desvenlafaxine) extended-release tablets

Venlafaxine (venlafaxine hydrochloride) extended-release tablets

 

False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine

 

FDA is evaluating the need for regulatory action.

Barium sulfate-containing products

• Entero Vu 24% (barium sulfate) oral suspension
• E-Z-Disk (barium sulfate) tablets
• Liquid E-Z-Paque (barium sulfate) oral suspension
• Readi-Cat 2 (barium sulfate) oral suspension
• Readi-Cat 2 Smoothie (barium sulfate) oral suspension
• Taglitol V (barium sulfate) oral suspension
• Varibar Honey (barium sulfate) oral suspension
• Varibar Nectar (barium sulfate) oral suspension
• Varibar Pudding (barium sulfate) oral paste
• Varibar Thin Honey (barium sulfate) oral suspension
• Varibar Thin Liquid (barium sulfate) oral suspension

Anaphylactic reaction FDA is evaluating the need for regulatory action.

Blincyto (blinatumomab) for injection

Columvi (glofitamab-gxbm) injection

Elrexfio (elranatamab-bcmm) injection

Epkinly (epcoritamab-bysp) injection

Imdelltra (tarlatamab-dlle) for injection

Kimmtrak (tebentafusp-tebn) injection

Lunsumio (mosunetuzumab-axgb) injection

Talvey (talquetamab-tgvs) injection

Tecvayli (teclistamab-cqyv) injection

 

 

Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action.

BRAF kinase inhibitors

• Braftovi (encorafenib) capsules
• Ojemda (tovorafenib) for oral suspension; tablets
• Tafinlar (dabrafenib) capsules; tablets
• Zelboraf (vemurafenib) tablets

Gingival hypertrophy FDA is evaluating the need for regulatory action.

Briumvi (ublituximab-xiiy) injection

Kesimpta (ofatumumab) injection

Acute hepatic failure

The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury.

Example: Briumvi labeling

 

Briumvi (ublituximab-xiiy) injection

Kesimpta (ofatumumab) injection

Ocrevus (ocrelizumab) injection

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection

Central nervous system infection FDA is evaluating the need for regulatory action.

Crexont (carbidopa and levodopa) extended-release capsules

Dhivy (carbidopa and levodopa) tablets

Duopa (carbidopa and levodopa) enteral suspension

Rytary (carbidopa and levodopa) extended-release capsules

Sinemet (carbidopa and levodopa) tablets

Sinemet CR (carbidopa and levodopa) sustained-release tablets

Stalevo (carbidopa, levodopa and entacapone) tablets

Vyalev (foscarbidopa and foslevodopa) injection

Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia

The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia.

Crysvita labeling

 

Dexmedetomidine-containing products

• Dexmedetomidine injection
• Precedex (dexmedetomidine hydrochloride) injection
• Igalmi (dexmedetomidine) sublingual film

Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action.

Eprontia (topiramate) oral solution

Qudexy XR (topiramate) extended-release capsules

Qsymia (phentermine and topiramate) extended-release capsules

Topamax (topiramate) tablets

Topamax Sprinkle (topiramate) capsules

Trokendi XR (topiramate) extended-release capsules

Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action.

Glucagon-like peptide-1 (GLP-1) receptor agonists

• Adlyxin (lixisenatide) injection
• Bydureon (exenatide) for extended-release injectable suspension
• Bydureon BCise (exenatide extended-release) injectable suspension
• Byetta (exenatide) injection
• Mounjaro (tirzepatide) injection
• Ozempic (semaglutide) injection
• Rybelsus (semaglutide) tablets
• Saxenda (liraglutide) injection
• Soliqua 100/33 (insulin glargine and lixisenatide) injection
• Trulicity (dulaglutide) injection
• Victoza (liraglutide) injection
• Wegovy (semaglutide) injection
• Xultophy 100/3.6 (insulin degludec and liraglutide) injection
• Zepbound (tirzepatide) injection

Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action.

Imbruvica (ibrutinib) capsules; tablets; oral suspension

 

Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action.

MEK inhibitors

• Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets)
• Cotellic (cobimetinib) tablets
• Mekinist (trametinib) tablets; oral solution
• Mektovi (binimetinib) tablets
• Koselugo (selumetinib) capsules

Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action.

Nurtec ODT (rimegepant) orally disintegrating tablets

Zavzpret (zavegepant) nasal spray

Anaphylactic reaction

The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis.

Example: Nurtec ODT labeling

 

Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors

 

Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction

The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions.

Vizamyl labeling

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