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The FDA has announced a Class II nationwide recall of TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, manufactured by Carolina Infusion LLC. This recall, initiated due to a lack of assurance of sterility, impacts single-use dosage syringes distributed across the U.S. Healthcare providers utilizing compounded medications, especially injectables, must be vigilant regarding product quality and patient safety.
The FDA has announced a Class II recall for compounded Semaglutide/Cyanocobalamin 9/2 mg/mL injectable, distributed nationwide by Carolina Infusion LLC. The recall was initiated due to a lack of assurance of sterility, specifically related to the formulation using bacteriostatic water and processing equipment. This affects single-use dosage syringes dispensed based on patient-specific prescriptions.
The Department of Justice's National Fraud Enforcement Division (Fraud Division) and the Department of Health and Human Services Office of Inspector General (HHS-OIG) have announced a new policy streamlining the self-disclosure process for potential criminal health care fraud. Companies now only need to disclose to the DOJ's Fraud Division to receive the benefits of both DOJ's Corporate Enforcement Policy and HHS-OIG's Health Care Fraud Self-Disclosure Protocol (SDP). This aims to reduce confusion and bureaucratic barriers, providing a clear pathway for organizations to report misconduct.
CVS Pharmacy has agreed to pay $315 million to resolve allegations that it illegally filled opioid prescriptions and submitted false claims to federal healthcare programs. The settlement addresses violations of the Controlled Substances Act and the False Claims Act, stemming from claims of dispensing medically unnecessary prescriptions and corporate practices that prioritized profits over patient safety. CVS will also implement new compliance safeguards through an agreement with the DEA.
The Drug Enforcement Administration (DEA) has issued a notice of intent to publish a new temporary order that will maintain the Schedule I status of two 7-hydroxymitragynine-related substances, MGM-15 and MGM-16. This action reaffirms their classification under the Controlled Substances Act, continuing the regulatory controls that have been in effect since August 26, 2026. The notice specifically distinguishes these substances from mitragynine pseudoindoxyl, addressing procedural clarity following a letter from the Department of Health and Human Services.
The FDA has issued a Request for Information (RFI) to gather public comments and data on the design and safety considerations for early-phase clinical trials involving ibogaine drug products. This initiative is prompted by federal funding for ibogaine research in opioid use disorder and PTSD, and aims to inform the FDA's review of future Investigational New Drug Applications.
Greenwich Rx, a 503A compounding pharmacy, has issued a voluntary nationwide recall for specific lots of its compounded Glutathione Injection (200 mg/mL). The recall is due to potential elevated endotoxin levels, which can lead to serious adverse health consequences including fevers, shock, and death. Healthcare providers and patients who received affected lots distributed between June and September 2026 are advised to cease use and follow recall instructions.
The U.S. Food and Drug Administration (FDA) has approved Emcitate (tiratricol) tablets for oral suspension, marking the first approved treatment for peripheral thyrotoxicosis in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. This approval addresses a significant unmet medical need for a very rare, devastating genetic disease that primarily affects males. Emcitate works by reducing excessive thyroid hormone levels in the bloodstream, leading to improvements in associated cardiovascular and metabolic symptoms.
Democratic state attorneys general are stepping up antitrust and healthcare enforcement as they perceive gaps left by federal regulators, with a particular focus on hospital mergers, private equity roll-ups, and nonprofit-to-for-profit conversions. Multistate coordination among AG offices is intensifying, meaning even smaller healthcare transactions that don't trigger federal review could draw state-level scrutiny. Healthcare operators — including telehealth brands, medspas, and other physician-affiliated businesses — should reassess their compliance posture through a state-level lens.
A Wyoming County, Pennsylvania physician was sentenced to 14 to 48 months in state prison after pleading guilty to unlawfully prescribing Schedule II controlled substances. The investigation found the doctor failed to assess abuse or overdose risk, lacked supporting patient documentation, and did not monitor patient responses to medications. The case, brought by the Pennsylvania Attorney General's Office, signals active state-level criminal enforcement against prescribing practices that fall below accepted standards of care.
CMS's proposed CY 2027 Physician Fee Schedule (CMS-1848-P, 91 FR 43842) would prohibit Medicare reimbursement for Remote Patient Monitoring and Remote Therapeutic Monitoring services performed by staff who are not direct employees of the billing practitioner or practice — effectively ending the widespread third-party vendor model. The rule also proposes new visit and patient relationship requirements, downward reimbursement rate adjustments, and new telehealth claim modifiers BB and BC. Providers currently relying on outsourced RPM/RTM vendors face a hard deadline of January 1, 2027 to restructure or discontinue those programs.
Houston-based Centric Compounding LLC has voluntarily recalled six lots of injectable Glutathione, Myer's Cocktail, and Tri-Immune Boost due to elevated endotoxin levels in the Glutathione API used to compound the products. FDA warns there is a reasonable probability these products could cause serious adverse events including fever, hypotension, anaphylactic shock, and death. The company has already received nine adverse event reports and is arranging replacement for all recalled products distributed nationwide.
The Department of Justice announced a $32 million settlement with Dompe US to resolve False Claims Act allegations. The drug manufacturer was accused of violating the Anti-Kickback Statute by using patient-assistance foundations to pay Medicare beneficiary co-pays for its drug, Oxervate, thereby inducing purchases.
The FDA has announced a Class II nationwide recall for specific lots of Semaglutide 2.5mg/Glycine 12.5mg sterile multi-dose vials, manufactured by Apollo Care, LLC. The recall was initiated due to the confirmed presence of particulate matter, identified as nylon/polyamide and silk/proteinaceous-type material, in the injectable product. This ongoing recall affects products distributed across the United States, underscoring the critical importance of supply chain vigilance for healthcare providers.
The U.S. Food and Drug Administration (FDA) has announced a Class II nationwide recall of SEMAGLUTIDE 0.9mg (0.9 mg/mL) 1 mL Sterile Multi-Dose Vials manufactured by Apollo Care, LLC. The recall was initiated due to the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. This recall affects product distributed nationwide within the U.S.
