Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Recall D-0018-2027 covers semaglutide 3 mg/mL injectable from Carolina Infusion, LLC, with FDA citing a lack of assurance of sterility; the recall is ongoing nationwide.
Carolina Infusion's compounded semaglutide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded in the FDA enforcement report under number D-0019-2027.
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%) is recalled across the US because sterility cannot be assured; the recall is ongoing.
The recall, numbered D-0026-2027 and still ongoing, concerns a compounded injectable and covers nationwide distribution within the US.
Polyvinyl alcohol 0.5% lubricant eye drops from K.C. Pharmaceuticals are subject to an ongoing nationwide US recall for lack of assurance of sterility.
The recall of tirzepatide 26 mg/mL injectable, distributed nationwide, cites lack of assurance of sterility linked to bacteriostatic water in the formulation and to processing equipment.
Biospectra, Inc. is recalling its Tris/Tromethamine product after it failed stability specifications, according to an FDA enforcement report entry that lists the recall as ongoing.
The compounded injectable is recalled nationwide in the US after the FDA cited a lack of assurance of sterility linked to bacteriostatic water and processing equipment.
The US enforcement report records an ongoing, nationwide recall of Eye Drops MAXIMUM, citing lack of assurance of sterility.
Carolina Infusion's tirzepatide/cyanocobalamin injectable is the subject of an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.
The agency's enforcement report records an ongoing nationwide recall of Sterile High Performance Ultra Lubricating Eye Drops, citing lack of assurance of sterility.
Carolina Infusion's compounded tirzepatide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded as D-0030-2027, due to a lack of assurance of sterility.
Carolina Infusion's Tri-MIX (PAPAV/PHENTO/ALPROS) is under an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.
The nationwide US recall of Lidocaine Ointment USP, numbered D-0013-2027, was logged in the FDA enforcement report on 14 October 2026 and remains ongoing.
The enforcement report entry, numbered D-0036-2027, cites lack of assurance of sterility and records the nationwide recall as ongoing.
The US regulator's enforcement report records an ongoing nationwide recall, D-0007-2027, for sterile eye drops from K.C. Pharmaceuticals, Inc., citing a lack of assurance of sterility.
Johnson & Johnson Innovative Medicine's IMAAVY injection is subject to an ongoing recall, numbered D-0016-2027, after particulate matter was identified, with distribution recorded in Ohio.
Cipla USA's Fosfomycin Tromethamine Granules for Oral Solution are subject to a nationwide Class II recall after failing impurities/degradation specifications, according to FDA's enforcement report.
K.C. Pharmaceuticals' eye drops are subject to an ongoing nationwide US recall, classified Class II, for lack of assurance of sterility.
Carolina Infusion's compounded tirzepatide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded as D-0027-2027, because sterility cannot be assured.
FDA's enforcement report lists a Class II recall of Carolina Infusion's papaverine, phentolamine, alprostadil and trimix-style injectable, citing processing equipment concerns; the recall is ongoing nationwide.
The US regulator's enforcement report records an ongoing recall of Sterile Lubricant Dry Eye Relief Eye Drops, distributed nationwide, citing lack of assurance of sterility.
The UK regulator's variations page, last revised on 14 October 2026, now covers batch release site deletions, Type II refusal appeals and Type IA annual updates.
The UK regulator has released five one-page guides setting out what its 2030 strategy means for healthcare professionals, innovators, industry, MedTech and patients.
The US regulator has issued the final version of its question-and-answer guidance on manufacturing changes made after licensure of biosimilar and interchangeable biosimilar products.
The EU regulator has issued the yearly report of the group of inspectors who work on pharmacovigilance inspection matters, covering the 2025 calendar year.
The UK regulator has published a knowledge and guidance hub on real-world data and evidence use in regulatory decision-making for medicines and medical devices.
The agency has published downloadable electronic Application Forms for initial MAAs, variations and renewals as a business continuity measure, with submission routes and validation requirements unchanged.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.