GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
A US federal court has sentenced the owner of TelevisitMD for a six-year scheme involving unneeded orthotic braces and genetic tests, with restitution and forfeiture ordered.
Germany's medicines and devices regulator has posted an urgent field safety notice from Stryker Spine-US on a spinal surgery wire, but the listing itself gives no details of the problem.
Germany's regulator has posted a manufacturer safety notice for SOLTIVE laser fibers, but the defect, affected lots and required actions appear only in the attached advisory.
Germany's BfArM has listed a manufacturer safety notice for BioFire Diagnostics' FilmArray Torch, but the listing gives no details of the issue or the actions required.
Germany's regulator has published a manufacturer advisory covering two Beckman Coulter centrifuge rotor assemblies, though the listing itself gives no detail on the problem or the actions required.
Germany's medicines and devices authority has posted a manufacturer advisory covering the Diomni Software, an in-vitro diagnostic product, though the published listing does not describe the underlying issue.
German regulator BfArM has published a manufacturer field safety notice covering Steriflush pre-filled water syringes, but the listing itself gives no details of the defect or affected lots.
US prosecutors allege sham addiction treatment, unnecessary atherectomies that injured patients, hospice fraud and bogus pharmacy prescriptions, in a case that includes six medical professionals.
Spain's regulator says French tests found 7.6% hydrogen peroxide in the TEMU-sold cosmetic, against a 0.1% limit for oral products.
Germany's medicines and devices authority has published a Boston Scientific field safety notice for OptiCross, but the listing itself does not describe the problem or the action required.
Houston Rx's tirzepatide and niacinamide 2 mL vials are being recalled nationwide in the US because sterility cannot be assured, and the recall is ongoing.
The recall of Zydus Pharmaceuticals (USA) Inc's hydrocortisone sodium succinate for injection, logged as D-0039-2027, is ongoing and covers nationwide distribution within the United States.
The recall, numbered D-0042-2027 and still ongoing, is classified as Class II and covers US nationwide distribution, according to the FDA enforcement report.
FDA's enforcement report lists a Class II recall of Teva Pharmaceuticals USA's metoclopramide tablets, with nationwide US distribution and the recall still ongoing.
The nationwide US recall of sermorelin from Houston Rx LLC, numbered D-0041-2027, is listed as ongoing in the FDA's enforcement report dated 21 October 2026.
The New Jersey compounder says analytical data from its own laboratory were inconsistent, so affected products may be subpotent or superpotent; 98 complaints have been received, 7 of them serious.
EOF has published a decision recalling specific lots of NEUROPACK straight plates and a sterile fast flap kit with a large bur hole, but the notice excerpt gives no reason or lot numbers.
Germany's medicines and devices regulator has listed an urgent field safety notice from Trinity Biotech covering an oxalate reagent and the kit that contains it, with details in the manufacturer's advisory.
Germany's regulator lists an urgent notice for Coltene/Whaledent's translucent esthetic post system, flagging a labelling problem and the absence of EU market permission.
Czech regulator reports that Accord's 120-tablet packs were supplied with an out-of-date patient information leaflet lacking updated adverse reactions.
Apothecary Pharma's NAD+ Injection 200 mg/mL is subject to an ongoing nationwide US recall, classified Class II for lack of assurance of sterility.
The US regulator's enforcement report records an ongoing nationwide recall of Sterile Eye Drops Redness Relief (glycerin 0.25%) because sterility cannot be assured.
The Class II recall of compounded sermorelin acetate 1 mg/ml injectable cites formulation with bacteriostatic water and processing equipment, and remains ongoing across the US.
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.
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.