The FDA Desk — 2026-07-10

TITLE: FDA Desk — July 10, 2026: Ten Class II recalls span drug mix-ups, nitrosamine impurities, and sterility failures

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Overview

No Class I recalls today. FDA's enforcement report posts ten firm-initiated Class II actions, clustering around three fault lines: foreign-substance and mix-up events in oral solid dosage, CGMP deviations (including a nitrosamine impurity finding), and sterility/formulation failures in hospital-facing products. All are voluntary, firm-initiated.

Contamination and product mix-ups (oral solids)

• D-0626-2026 — Annora Pharma Pvt. Ltd. (Sangareddy, India), manufacturing for Camber Pharmaceuticals, recalled Lacosamide Tablets USP 100 mg, 60-count (NDC 31722-813-60) after a complaint indicated possible cross-contamination with Selexipag 1000 mcg tablets — a Schedule V/pulmonary-hypertension mix-up with meaningful clinical exposure risk.
• D-0615-2026 and D-0612-2026 — Amgen recalled Italy-manufactured Corlanor (ivabradine) tablets in both 7.5 mg 60-count (NDC 55513-810-60) and 5 mg 14- and 60-count presentations (NDC 55513-800-99 / -60) for presence of a foreign substance. The paired lot actions suggest a shared manufacturing-line event rather than an isolated complaint.

CGMP deviations, including a nitrosamine finding

• D-0617-2026 — Direct Rx repackaged Duloxetine DR 30 mg (NDC 61919-482-30 and -60), marketed as Cymbalta, is being recalled for N-nitroso-duloxetine impurity above FDA's recommended interim limit — the notable item of the day given continuing agency scrutiny of nitrosamines in SSRIs/SNRIs.
• D-0611-2026 — Ajanta Pharma USA recalled Fenofibrate Capsules USP 200 mg, 100-count (NDC 27241-120-04), manufactured by Ajanta Pharma Ltd. (India), for unspecified CGMP deviations.
• D-0614-2026 — Amgen recalled Sensipar (cinacalcet) 60 mg, 30-count bottles (NDC 55513-074-30), Japan-manufactured, also for CGMP deviations — a second Amgen entry today, distinct from the Corlanor foreign-substance actions.

Sterility and formulation failures (hospital and clinic use)

• D-0622-2026 and D-0623-2026 — CareFusion 213, LLC (a BD subsidiary, El Paso, TX) recalled two BD ChloraPrep applicator configurations — the 1 mL Clear (60-ct) and the 1.5 mL FREPP Clear (20-ct), each 2% CHG / 70% IPA — citing lack of assurance of sterility due to wrinkles in the paper lidding that may breach the seal. Given ChloraPrep's routine pre-procedural use, hospitals should verify inventory against affected lots.
• D-0618-2026 — Central Admixture Pharmacy Services (CAPS), Boston, recalled a patient-specific pediatric TPN bag (Rx# 24-1269856-0-1, 1295 mL) because the compounded bag did not contain copper and famotidine as labeled — a single-patient compounding error, but a reminder of the residual risk profile of outsourced pediatric PN.
• D-0627-2026 — Elevate Oral Care recalled Povi-One 10% Povidone-Iodine Oral Antiseptic (NDC 57511-0611-1) for subpotency, degrading its utility as a perioperative/dental antiseptic.

Editor's read

Two threads worth watching: (1) Amgen appears in three separate entries today across two manufacturing sites (Italy, Japan) and two failure modes (foreign substance, CGMP), warranting a closer look at supplier oversight; (2) the Direct Rx duloxetine action extends the nitrosamine impurity story into repackaged SNRIs, and downstream repackagers should expect continued limit-based enforcement.