The FDA Desk — 2026-07-13
TITLE: FDA Desk: 10 Class II Recalls — Amgen Cardiac Drugs, BD Sterility Issue, TPN Compounding Error
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No Class I recalls were posted today; all ten actions below are Class II, firm-initiated, voluntary recalls.
Amgen: Three Products, One Manufacturing Thread
Amgen Inc. (Thousand Oaks, CA) has three separate Class II recalls tied to its Italy- and Japan-manufactured products. D-0615-2026 and D-0612-2026 cover Corlanor (ivabradine) tablets, 7.5mg and 5mg respectively, both recalled for presence of a foreign substance. D-0614-2026 pulls Sensipar (cinacalcet) 60mg tablets for CGMP deviations. The clustering of contamination and quality findings across Amgen's cardiac/renal portfolio warrants a closer look at whether a shared supply chain or facility issue is at play.
BD ChloraPrep: Sterility Assurance Gap
CareFusion 213 (a Becton, Dickinson subsidiary) recalled two ChloraPrep antiseptic applicator lines — D-0622-2026 (Clear, 1 mL, 60-count) and D-0623-2026 (FREPP Clear, 1.5 mL, 20-count) — after identifying wrinkles in the paper lidding that could breach seal integrity and compromise sterility, a concern for products used in skin prep before invasive procedures.
Contamination and Mix-Up Risk
Annora Pharma's D-0626-2026 recall of Lacosamide Tablets 100mg (manufactured for Camber Pharmaceuticals) followed a complaint of a possible mix-up with Selexipag 1000 mcg tablets in the same bottle — a mislabeling risk with serious dosing implications given lacosamide's anticonvulsant indication.
Impurity and CGMP Findings
Direct Rx's D-0617-2026 recall targets Duloxetine D/R capsules (30mg, both 30- and 60-count) due to N-nitroso-duloxetine impurity levels exceeding FDA's interim limit, continuing the broader industry pattern of nitrosamine-related recalls. Separately, Ajanta Pharma USA's D-0611-2026 pulled Fenofibrate Capsules USP 200mg over unspecified CGMP deviations.
Formulation and Potency Errors
Central Admixture Pharmacy Services' D-0618-2026 recall involves a patient-specific pediatric TPN bag that was missing copper and famotidine per its label — a compounding error with direct clinical risk for the pediatric patient it was intended for. Elevate Oral Care's D-0627-2026 recalled Povi-One 10% Povidone-Iodine Oral Antiseptic for sub-potency, reducing its antiseptic efficacy.