The FDA Desk — 2026-05-23

TITLE: FDA Desk — May 23, 2026: Nitrosamine recalls widen across duloxetine; CAPS TPN bag missing insulin

---

Lead Items

No Class I recalls posted today. The most clinically consequential entry is a compounded TPN error: D-0524-2026, a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) from Central Admixture Pharmacy Services (CAPS) Los Angeles, was recalled Class II after the firm determined the product was dispensed without the insulin listed on the label — a formulation error with direct dosing implications for the receiving patient.

Nitrosamine Cluster — Duloxetine Delayed-Release Capsules

Three separate Class II recalls posted today share a common defect: N-nitroso-duloxetine impurity exceeding the FDA-recommended 0.83 ppm limit, identified at 12- and 18-month long-term stability pulls. The pattern suggests an industry-wide stability-aging issue rather than a single-site CGMP failure.

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (marketed by Ajanta Pharma USA, Bridgewater NJ; made in India) recalled duloxetine DR capsules 30 mg (90-, 30-, and 1000-count; NDC 27241-098-xx) and 20 mg (60-count; NDC 27241-097-06) on 2026-04-29 for nitrosamine excursions at long-term stability intervals.
• D-0522-2026 — Breckenridge Pharmaceutical (Berkeley Heights NJ), product manufactured by Towa Pharmaceutical Europe S.L. (Barcelona), recalled duloxetine DR 60 mg, 90-count (NDC 51991-748-90) on 2026-04-21 for the same N-nitroso-duloxetine CGMP deviation, confirming the impurity is not confined to a single API source.

Pharmacists and dispensers should expect additional duloxetine lots to follow as ongoing stability programs read out.

Sterility and Contamination

• D-0518-2026 and D-0517-2026 — CareFusion 213, LLC (El Paso TX; a Becton Dickinson subsidiary) recalled two BD PurPrep configurations — povidone-iodine 8.3% / isopropyl alcohol 72.5% sterile solution applicators (10.5 mL × 25/box; and 26 mL × 25/carton, NDC 54365-014-42) — Class II on 2026-04-22 for lack of sterility assurance due to potential contamination. Preoperative skin-prep users should quarantine remaining stock pending lot verification.
• D-0523-2026 — Acella Pharmaceuticals (Alpharetta GA) recalled Naproxen Oral Suspension USP 125 mg/5 mL, 473 mL bottles (NDC 42192-619-16; made in Canada) on 2026-04-20 after chemical testing showed lead and lithium above specification — a heavy-metal contamination event in a pediatric-dosable liquid that warrants prompt clinician notice.

Impurity and Potency Failures

• D-0520-2026 — Enalapril Maleate Tablets USP 20 mg, 1,000-count bottles, manufactured by Unique Pharmaceutical Laboratories (J.B. Chemicals & Pharmaceuticals, Mumbai) and distributed by Rising Pharma Holdings, were recalled Class II on 2026-04-23 for out-of-specification organic impurities/degradation results.
• D-0511-2026 — Unichem Pharmaceuticals (USA) recalled buspirone HCl 5 mg tablets, 500-count bottles (manufactured by Unichem Laboratories, Ghaziabad, India) Class III on 2026-04-13 for subpotency. The lower classification reflects limited acute risk, but anxiolytic underdosing is clinically relevant for stabilized patients.

Pending Classification

• A B. Braun Medical (Bethlehem PA) recall of Lactated Ringer's Injection USP, 1000 mL (NDC 0264-7750-07) was initiated 2026-04-28 for visible particulate matter. Classification is not yet assigned; given the IV route and high-volume use, facilities should pre-emptively check inventory against B. Braun's lot notice and expect a likely Class II designation.

Editor's Note

Today's docket is dominated by two themes regulators and quality teams should track: (1) the continuing expansion of nitrosamine findings into duloxetine across multiple API sources and finished-dose manufacturers, mirroring the earlier sartan and ranitidine arcs; and (2) two distinct contamination signals — sterility loss in BD PurPrep applicators and heavy-metal contamination in Acella's naproxen suspension — that together suggest renewed FDA attention to incoming-materials and environmental controls at contract sites. No Class I actions were posted.