The FDA Desk — 2026-05-21

TITLE: FDA Desk — May 21, 2026: Duloxetine nitrosamine cluster, BD PurPrep sterility, and a TPN missing insulin

---

Top Line

No Class I recalls posted today. The day's docket is dominated by Class II actions clustered around three themes: a nitrosamine-impurity cluster sweeping the duloxetine market, repeat sterility failures at CareFusion's BD PurPrep antiseptic line, and a compounding-pharmacy formulation error in a patient-specific TPN. One Class III subpotency action and one unclassified B. Braun particulate recall round out the list.

Compounding & Hospital Pharmacy

• D-0524-2026 — Central Admixture Pharmacy Services (CAPS) of Santa Fe Springs, CA initiated a Class II recall of a patient-specific 1,660 mL TPN bag (Rx# 11-4909703-0-1) on 2025-12-27 after the compounded product was dispensed without the labeled insulin — a formulation error with direct glycemic-management implications for the single identified patient.
• Not Yet Classified — B. Braun Medical (Bethlehem, PA) initiated a voluntary recall on 2026-04-28 of Lactated Ringer's Injection USP, 1000 mL (NDC 0264-7750-07) for presence of particulate matter; classification pending, but particulate findings in large-volume IV solutions typically draw Class II treatment pending patient-harm assessment.

Nitrosamine Cluster: Duloxetine Delayed-Release Capsules

Three separate Class II recalls posted today share a common root cause — N-nitroso-duloxetine above the FDA-recommended 0.03 ppm/0.83 ppm threshold detected at 12- and 18-month long-term stability pulls — signaling a stability-driven, industry-wide CGMP problem rather than isolated batch failures.

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India), marketed via Ajanta Pharma USA, recalled duloxetine DR capsules 30 mg (90/30/1000-ct, NDC 27241-098-*) and 20 mg (60-ct, NDC 27241-097-06) on 2026-04-29 for the nitrosamine exceedance.
• D-0522-2026 — Breckenridge Pharmaceutical (Berkeley Heights, NJ), with API/finished product from Towa Pharmaceutical Europe S.L. (Spain), recalled duloxetine DR 60 mg, 90-ct (NDC 51991-748-90) on 2026-04-21 for the same N-nitroso-duloxetine CGMP deviation — confirming the impurity is not site-specific to Ajanta.

Dispensers and 503B repackagers holding duloxetine inventory across multiple suppliers should review lot-level stability data; the cross-manufacturer pattern suggests further actions are likely.

Antiseptics: BD PurPrep Sterility

• D-0517-2026 and D-0518-2026 — CareFusion 213, LLC (El Paso, TX), a Becton Dickinson subsidiary, initiated paired Class II recalls on 2026-04-22 of BD PurPrep povidone-iodine 8.3% / isopropyl alcohol 72.5% sterile applicators in both 10.5 mL (25/box) and 26 mL (25/carton, NDC 54365-014-42) configurations for lack of assurance of sterility. A surgical-prep antiseptic failing sterility assurance is a meaningful infection-control exposure for OR and procedural settings; facilities should quarantine affected lots and verify alternate-supplier availability.

Other Oral Solids and Liquids

• 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 for chemical contamination — lead and lithium above specification. Heavy-metal exceedance in a pediatric-friendly liquid formulation warrants particular attention from pediatric and long-term-care dispensers.
• D-0520-2026 — Unique Pharmaceutical Laboratories (a JB Chemicals & Pharmaceuticals division, Mumbai), distributed by Rising Pharma Holdings, recalled enalapril maleate tablets USP 20 mg, 1,000-ct bottles on 2026-04-23 for out-of-specification organic-impurity results — a degradation/impurity failure relevant to chronic ACE-inhibitor therapy.
• D-0511-2026 — Unichem Pharmaceuticals USA (East Brunswick, NJ), with finished product from Unichem Laboratories Ltd. (Ghaziabad, India), initiated a Class III recall on 2026-04-13 of buspirone HCl tablets USP 5 mg, 500-ct bottles, for subpotency. Class III signals low likelihood of adverse health consequence, but anxiolytic subpotency can still produce breakthrough symptoms in stabilized patients.

Editor's Note

Two patterns warrant follow-up: (1) the duloxetine N-nitroso impurity is now documented across at least two unrelated manufacturers (Ajanta/India and Towa/Spain) on long-term stability, suggesting the FDA's nitrosamine surveillance program will continue producing recalls in this molecule for several more cycles; (2) CareFusion's repeat sterility actions on BD PurPrep merit a look at the El Paso facility's inspection history. We will track both.