The FDA Desk — 2026-07-11
TITLE: All-Class II Day: Mix-Ups, Sterility Gaps, and CGMP Deviations Across 10 FDA Recalls
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No Class I recalls posted today — all ten actions are Class II, firm-initiated, and voluntary. Still, several raise meaningful safety concerns worth flagging.
Mix-Up and Contamination Risks
D-0626-2026 is the most acute item on the list: Camber Pharmaceuticals/Annora Pharma is recalling Lacosamide Tablets, USP, 100mg (NDC 31722-813-60) after a complaint that a bottle contained a Selexipag 1000 mcg tablet instead — a mix-up that could expose an anti-seizure patient to an unrelated pulmonary hypertension drug. D-0615-2026 and D-0612-2026 cover Amgen's Corlanor (ivabradine) tablets, 7.5mg and 5mg strengths respectively, both recalled for presence of a foreign substance in the tablets.
Sterility and Formulation Failures
Beckton Dickinson subsidiary CareFusion is pulling two BD ChloraPrep antiseptic applicator lines — D-0622-2026 (Clear, 1 mL) and D-0623-2026 (FREPP Clear, 1.5 mL) — both due to wrinkles in the paper lidding that may breach the sterile seal, undermining the sterility assurance these skin-prep products are meant to guarantee. Separately, D-0618-2026 flags a patient-specific compounded Total Parenteral Nutrition bag from Central Admixture Pharmacy Services that was missing copper and famotidine called for on the label — a formulation error with direct clinical implications for the intended recipient.
CGMP and Potency Deviations
Three items stem from manufacturing-quality issues rather than acute safety events: D-0611-2026 (Ajanta Pharma's Fenofibrate Capsules, 200mg) and D-0614-2026 (Amgen's Sensipar (cinacalcet) 60mg tablets) were both recalled for CGMP deviations. More concerning is D-0617-2026, Direct Rx's repackaged Duloxetine D/R / Cymbalta capsules (30mg, in 30- and 60-count bottles), pulled after detection of N-nitroso-duloxetine impurity above the FDA's recommended interim limit — part of the broader nitrosamine-impurity scrutiny affecting generic drug supply chains. Rounding out the list, D-0627-2026 covers Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic, recalled for sub-potency.