Recalls, safety notices, approvals and label changes for the drugs on this site,
each linked to the official notice it came from.
Data sourced from FDA Drug Safety ↗,
FDA Recalls ↗,
and DailyMed ↗.
APPROVAL··US
Sidhelo (donidalorsen) approved for on-demand treatment of hereditary angioedema attacks
FDA approved donidalorsen (Sidhelo; Kalvista Pharmaceuticals) oral tablets for on-demand treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older. Donidalorsen is a plasma kallikrein inhibitor; the approval was supported by the ZENITH-1 phase 3 trial showing significant reduction in attack severity and time to symptom relief vs placebo. It is the first oral on-demand HAE therapy.
FDA approved a labelling update for Mounjaro (tirzepatide; Eli Lilly) to include reduction in the risk of a composite kidney outcome in adults with type 2 diabetes and chronic kidney disease, based on the SURPASS-CVOT renal substudy and the dedicated SURPASS-CKD trial data. The update extends tirzepatide's cardiovascular-renal benefit profile alongside the existing glycaemic control and weight management indications.
FDA updated labelling for all SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin, ertugliflozin) to include enhanced warnings about Fournier's gangrene (necrotising fasciitis of the perineum) — a rare but life-threatening infection. The update adds specific guidance on risk factors, early recognition signs, and the need for immediate discontinuation and surgical assessment.
FDA granted traditional approval to donanemab (Kisunla; Eli Lilly) for adults with early symptomatic Alzheimer's disease — converting the accelerated approval granted in July 2024. The confirmatory TRAILBLAZER-ALZ 2 trial showed a statistically significant 35% slowing of clinical decline on the iADRS composite scale vs placebo at 76 weeks. The label supports treatment discontinuation once amyloid plaque clearance is confirmed by PET or CSF.
FDA approved a supplemental label for Cobenfy (xanomeline and trospium chloride; Bristol Myers Squibb), the first muscarinic agonist for schizophrenia, to include a maintenance-of-effect indication. The update is supported by the EMERGENT-4 long-term extension trial demonstrating sustained symptom control and a favourable tolerability profile over 52 weeks without dopamine D2 blockade.
Greenwich Rx issued a voluntary nationwide recall of compounded Glutathione Injection due to potential elevated endotoxin levels. Endotoxin contamination can cause fever, chills, low blood pressure, and septic shock in patients receiving injections. Affected lots should not be administered; pharmacies are asked to quarantine and return stock.
DrugTheGuide's first drug page covers ibuprofen (racemate, dexibuprofen, lysine and sodium salt variants) with pharmacokinetic tiles sourced from FDA product labels and PubChem, an interactive one-compartment dose-curve simulator, a ball-and-stick structure viewer, and the variants comparison table.
FDA expanded the Camzyos label to include patients aged 12 to under 18 with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) — the first cardiac myosin inhibitor approved for this age group. The decision was supported by the phase 3 SCOUT-HCM trial, in which mavacamten significantly reduced outflow-tract gradient vs placebo at 28 weeks.
FDA approved tiratricol (Emcitate; Egetis Therapeutics) oral tablets for peripheral thyrotoxicosis in patients with MCT8 deficiency (Allan-Herndon-Dudley syndrome). Tiratricol is a thyroid hormone receptor agonist that bypasses the defective MCT8 transporter, addressing a disorder that previously had no approved US therapy.
FDA approved zilurgisertib (Atebrioz; Mirum Pharmaceuticals / Incyte), an ALK2 inhibitor, to reduce new heterotopic ossification in patients aged 12 years and older with FOP. In the PROGRESS trial, mean new lesion volume decreased by 3.2 cm³ with zilurgisertib vs an increase of 24.6 cm³ on placebo at week 24.
Otsuka ICU Medical LLC voluntarily recalled lots of 0.9% Sodium Chloride Injection USP 100 mL because the overwrap may contain a 10 mEq Potassium Chloride Injection bag. An inadvertent KCl infusion carries risk of cardiac arrhythmia and death. Healthcare facilities are asked to quarantine all affected lots immediately.
FDA approved additional labelling for Kybella warning of adverse reactions associated with unapproved uses beyond submental fat. The safety communication notes reports of tissue injury when the product is used outside its approved injection site.
FDA approved a new indication for Wegovy (semaglutide 2.4 mg injection; Novo Nordisk) to improve exercise tolerance and quality of life in adults with heart failure with preserved ejection fraction (HFpEF) and obesity — based on the STEP-HFpEF and STEP-HFpEF DM trials. The label now supports use in patients with BMI ≥ 30 kg/m² or ≥ 27 kg/m² with obesity-related comorbidities and HFpEF.
FDA issued updated guidance requiring enhanced gastrointestinal bleeding risk warnings on all OTC NSAID labels, including ibuprofen and naproxen. The update follows a systematic review of FAERS reports and epidemiological data showing underappreciation of GI risk in consumers using NSAIDs for pain relief at labelled doses.
FDA added a Boxed Warning — the agency's strongest label caution — to Injectafer (ferric carboxymaltose injection) to describe the risk of severe and symptomatic low phosphate levels. Clinicians are advised to check serum phosphate before and after infusion in patients at risk.
FDA approved a label expansion for Ozempic (semaglutide injection; Novo Nordisk) to include reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease, based on the SELECT and SUSTAIN-6 trial data. The indication joins the existing glycaemic control label.
FDA granted traditional approval to lecanemab (Leqembi; Eisai/Biogen) for early Alzheimer's disease — converting the January 2023 accelerated approval. The decision was supported by the phase 3 CLARITY AD trial showing a statistically significant 27% slowing of clinical decline on the CDR-SB scale vs placebo at 18 months. Medicare coverage expanded alongside full approval.
FDA approved labelling changes for the OTC weight-loss drug Alli (orlistat 60 mg) to warn patients of the risk of kidney stones and acute kidney injury. Consumers are advised to stop use and seek medical attention if they develop symptoms such as back or side pain, blood in urine, or decreased urine output.
FDA identified cases of serious liver injury, including drug-induced liver injury (DILI) with hepatic failure, in patients taking Tavneos (avacopan) for severe active ANCA-associated vasculitis. Updated labelling now includes enhanced liver monitoring requirements and guidance on when to discontinue therapy.
FDA required a new warning about vitamin B6 (pyridoxine) deficiency and associated seizures for drug products containing carbidopa/levodopa. Carbidopa inhibits aromatic L-amino acid decarboxylase, which uses B6 as a cofactor; prolonged use can deplete systemic B6 stores.
Following a comprehensive review of post-market data and clinical trial results, FDA requested removal of the suicidal behaviour and ideation warning from labelling for GLP-1 receptor agonist (GLP-1 RA) medications including semaglutide, liraglutide, and dulaglutide. The review found no causal evidence linking these drugs to suicidality.
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Frequently asked questions
Where does the information on this page come from?
Every item is sourced from an official regulatory body or from DrugTheGuide itself (site updates). Regulatory items link directly to the original notice on FDA.gov ↗, DailyMed ↗, or the relevant agency website. We do not publish items without a primary source.
What is the difference between a Recall and a Safety notice?
A Recall means a product or batch is being physically removed from the market — pharmacies must return or destroy stock. A Safety notice (FDA Drug Safety Communication ↗) means the FDA has published a new warning or required a label update, but the product remains available. Both types appear on the FDA Drug Safety and Availability page ↗.
Should I stop taking a drug that appears in the news?
No — do not stop or change a medicine because of a news item without speaking to a pharmacist or doctor first. Recalls affect specific lots and strengths, not all products with that name. Safety notices may apply only to certain doses, durations, or patient groups. Check the original notice (linked in each item) or contact the FDA MedWatch program ↗ for the exact scope.
How do I report a side effect or product problem?
In the US, patients and healthcare providers can report adverse events and product problems via FDA MedWatch ↗ online or by calling 1-800-FDA-1088. Reports feed into the FAERS database ↗, which helps the FDA detect safety signals early.
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DrugTheGuide is a static site rebuilt on a scheduled basis. We aim to reflect major FDA recalls and safety communications within a few days of publication. For time-critical safety information, always check FDA Drug Safety and Availability ↗ directly. You can also subscribe to FDA recall alerts ↗ by email.