The FDA Desk — 2026-07-12
TITLE: FDA Desk: No Class I Recalls Today — Amgen, BD, and Duloxetine Impurity Lead Class II Actions
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No Class I recalls were posted today; all ten actions logged by FDA are Class II, spanning contamination, formulation, and sterility concerns across cardiac, antiseptic, and compounded-nutrition products.
Amgen: Three Products, One Recurring Defect Code
Amgen initiated voluntary recalls on three separate products for presence of foreign substance/CGMP deviations, all logged 2026-06-04. D-0615-2026 covers Corlanor (ivabradine) 7.5mg tablets (NDC 55513-810-60) and D-0612-2026 covers Corlanor 5mg tablets in both 14- and 60-count bottles (NDC 55513-800-99/-60), both manufactured in Italy for foreign substance contamination. D-0614-2026 pulls Sensipar (cinacalcet) 60mg tablets (NDC 55513-074-30), made in Japan, over CGMP deviations. The clustering of three distinct Amgen products in a single week's recall log warrants scrutiny of whether these stem from a common upstream supplier or packaging line issue.
Sterility and Mix-Up Risks in Dispensed Medications
D-0626-2026 flags a serious dispensing mix-up: Annora Pharma's Lacosamide Tablets USP 100mg (NDC 31722-813-60, manufactured for Camber Pharmaceuticals) may contain misplaced Selexipag 1000mcg tablets in the same bottle — a foreign-tablet contamination confirmed via complaint, posing risk of inadvertent pulmonary hypertension drug exposure to seizure patients. Separately, CareFusion 213 (a BD subsidiary) recalled two BD ChloraPrep antiseptic applicator lines — D-0622-2026 (Clear, 1mL, 60-count, NDC 54365-4) and D-0623-2026 (FREPP Clear, 1.5mL, 20-count) — both dated 2026-05-28, due to wrinkles in paper lidding that may breach seal integrity and compromise sterility assurance for these pre-surgical skin-prep products.
CGMP and Potency Failures
D-0611-2026 recalls Ajanta Pharma's Fenofibrate Capsules USP 200mg (NDC 27241-120-04) over unspecified CGMP deviations. D-0627-2026 pulls Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic (NDC 57511-0611-1) for sub-potency, meaning the antiseptic may fail to deliver labeled germicidal strength. Most notably, D-0617-2026 recalls Direct Rx's repackaged Duloxetine D/R 30mg capsules (Cymbalta, NDC 61919-482-30 and -60) after detecting N-nitroso-duloxetine impurity above FDA's interim recommended limit — the latest entry in FDA's ongoing nitrosamine-impurity surveillance across generic and repackaged antidepressants.
Compounding Error in Pediatric Nutrition
D-0618-2026 recalls a patient-specific Pediatric TPN bag (Rx# 24-1269856-0-1, 1295mL) compounded by Central Admixture Pharmacy Services in Boston, after the bag was found to omit copper and famotidine required by the prescription label — a formulation error in a single-dose injectable product intended for a vulnerable pediatric patient, underscoring compounding-pharmacy quality-control risk.