FDA Enforcement · May 27, 2026
Drug recall: Liraglutide Injection, 18 mg/3 mL (6 mg/mL)
Presence of particulate matter: a white thread-like structure in the cartridge — Lupin Pharmaceuticals Inc. · Class II · Ongoing · 217,621 pen injectors
Latest medical news · page 227
The latest headlines across every section, pulled from official and open-access sources.
FDA Enforcement · May 27, 2026
Drug recall: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit — Zydus Pharmaceuticals (USA) Inc · Class II · Ongoing · 23,880 bottles
FDA Enforcement · May 27, 2026
Drug recall: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Amerisource Health Services LLC · Class III · Ongoing · 225,000 tablets
FDA Enforcement · May 27, 2026
Drug recall: Primidone Tablets, USP, 50 mg, 50-count bottle
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Golden State Medical Supply Inc. · Class III · Ongoing · 8,526 bottles
FDA Enforcement · May 27, 2026
Drug recall: Primidone Tablets, USP, 250 mg, 100-count bottle
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Golden State Medical Supply Inc. · Class III · Ongoing · 1,620 bottles
FDA Enforcement · May 27, 2026
Drug recall: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%)
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. — Wisconsin Pharmacal Company · Class I · Ongoing · 690 tubes
FDA Enforcement · May 27, 2026
Drug recall: cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose)
Lack of Assurance of Sterility — UCB Biosciences Inc. · Class II · Ongoing · 141,708 cartons
FDA Enforcement · May 27, 2026
Drug recall: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Amerisource Health Services LLC · Class III · Ongoing · 63,500 tablets
FDA Enforcement · May 27, 2026
Drug recall: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton
Defective Container; packets were found to be either empty or partially full. — ANI Pharmaceuticals, Inc. · Class II · Ongoing · 3964 Cartons
FDA Enforcement · May 27, 2026
Drug recall: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials
Failed Impurities/Degradation Specifications — Sagent Pharmaceuticals · Class III · Ongoing · Lot 656412: 6,200 vials. Lot 659646: 3,328 vials
FDA Enforcement · May 27, 2026
Drug recall: Primidone Tablets USP, 250mg, 100-count bottle
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Lannett Company Inc. · Class III · Ongoing · 44865 bottles
FDA Enforcement · May 27, 2026
Drug recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. — Haleon US Holdings LLC · Class II · Ongoing · 285,330 blister cards
FDA Enforcement · May 27, 2026
Drug recall: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799…
Presence of a Foreign Substance; black particles observed in liquid — Safecor Health, LLC · Class II · Ongoing · 520 syringes
FDA Enforcement · May 27, 2026
Device recall: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. — Becton, Dickinson and Company · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064),…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and display… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Swan-Ganz Pacing Catheter, Models: D200F7;
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. — Becton, Dickinson and Company · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass…
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product…
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
FDA Enforcement · May 27, 2026
Device recall: OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7…
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant. — Novapproach Spine, LLC · Class II · Ongoing