Consumer Recalls Daily — 2026-07-11

TITLE: FDA Posts 10 Class II Drug Recalls Spanning Amgen, Ajanta, Direct Rx; CPSC Feed Down

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CPSC Consumer Products

The CPSC recall feed returned an error today ("Error retrieving Recalls: The underlying provider failed on Open"), so no consumer product recalls can be reported. We'll retry in the next edition.

FDA Recalls — 10 Class II Actions

No Class I actions today, but two items stand out for direct patient-safety risk and should top the list.

Lead items — highest concern:

• D-0626-2026: Camber Pharmaceuticals (mfg. Annora Pharma, Telangana, India) is pulling Lacosamide Tablets USP 100mg, 60-count, NDC 31722-813-60 after a complaint found a Selexipag 1000mcg tablet mixed into a lacosamide bottle — a wrong-drug mix-up that could cause serious dosing errors for epilepsy/seizure patients.
• D-0618-2026: Central Admixture Pharmacy Services (Boston) recalled a patient-specific pediatric TPN bag (Rx# 24-1269856-0-1, 1295 mL) after the compounded formulation omitted copper and famotidine required by the label — a critical gap for a vulnerable pediatric patient on total parenteral nutrition.

Foreign substance / contamination:

• D-0615-2026 and D-0612-2026: Amgen recalled two strengths of Corlanor (ivabradine) — 7.5mg 60-count bottles (NDC 55513-810-60) and 5mg in both 14-count (NDC 55513-800-99) and 60-count (NDC 55513-800-60) bottles — all made in Italy, over presence of a foreign substance in the tablets.
• D-0622-2026 and D-0623-2026: CareFusion 213 (BD subsidiary) recalled two BD ChloraPrep antiseptic applicator lots — ChloraPrep Clear (1 mL, 60-count, NDC 54365-4) and ChloraPrep FREPP Clear (1.5 mL, 20-count) — after wrinkles in the paper lidding raised concerns the seal could be breached, risking loss of sterility assurance.

Manufacturing/impurity deviations:

• D-0617-2026: Direct Rx recalled Duloxetine D/R (generic Cymbalta) 30mg, in both 30-count and 60-count bottles (NDC 61919-482-30/60), due to N-nitroso-duloxetine impurity levels above FDA's interim safety limit — the latest in an ongoing wave of nitrosamine-related generic recalls.
• D-0611-2026: Ajanta Pharma USA recalled Fenofibrate Capsules USP 200mg, 100-count (NDC 27241-120-04), manufactured by Ajanta Pharma Limited in India, citing broader CGMP deviations at the manufacturing site.
• D-0614-2026: Amgen recalled Sensipar (cinacalcet) 60mg tablets, 30-count bottles (NDC 55513-074-30), made in Japan, also for CGMP deviations.

Potency issue:

• D-0627-2026: Elevate Oral Care recalled Povi-One 10% Povidone-Iodine Oral Antiseptic (NDC 57511-0611-1) after testing found the product was sub-potent, potentially undermining its antiseptic effectiveness.

All ten FDA actions are firm-initiated, voluntary Class II recalls dated between 2026-05-28 and 2026-06-22; none carry confirmed injury or death reports as of this posting, but the lacosamide/selexipag mix-up and pediatric TPN formulation error warrant the closest pharmacy and hospital attention.