The FDA Desk — 2026-05-24

TITLE: FDA Desk — May 24, 2026: Nitroso-Duloxetine Sweep, BD PurPrep Sterility Failures, Heavy Metals in Pediatric Naproxen

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Top of the Docket

No Class I recalls were posted today. The day's signal is dominated by a multi-firm N-nitroso-duloxetine impurity sweep, two BD PurPrep antiseptic sterility recalls, and a chemical contamination finding in a pediatric naproxen oral suspension.

Nitrosamine Impurity Sweep — Duloxetine DR Capsules

A coordinated wave of Class II recalls hit duloxetine delayed-release capsules this cycle, all citing CGMP deviations and detection of N-nitroso-duloxetine above the FDA-recommended 0.83 ppm limit at 12- and 18-month long-term stability intervals — suggesting an on-shelf, time-dependent impurity formation issue rather than a release-testing failure.

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India) is recalling duloxetine DR 30 mg (90-, 30-, and 1000-count, NDC 27241-098-xx) and 20 mg (60-count, NDC 27241-097-06), marketed via Ajanta Pharma USA, initiated 2026-04-29.
• D-0522-2026 — Breckenridge Pharmaceutical is recalling duloxetine DR 60 mg, 90-count (NDC 51991-748-90), manufactured by Towa Pharmaceutical Europe (Spain), initiated 2026-04-21. The cross-supplier pattern — Indian and European API/finished-dose makers both implicated — suggests the impurity is intrinsic to the molecule's degradation pathway and warrants pharmacist-level dispensing review across the duloxetine class.

Sterility and Contamination Risks

• D-0518-2026 and D-0517-2026 — CareFusion 213, LLC (a Becton Dickinson subsidiary, El Paso, TX) is recalling two configurations of BD PurPrep povidone-iodine/IPA sterile applicators (10.5 mL ×25/box; 26 mL ×25/carton, NDC 54365-014-42) for "lack of assurance of sterility — potential product contamination," initiated 2026-04-22. Because PurPrep is widely used for pre-procedural skin antisepsis, contaminated lots create a direct surgical-site-infection vector; ORs and procedural suites should quarantine stock immediately.
• D-0523-2026 — Acella Pharmaceuticals is recalling Naproxen Oral Suspension USP, 125 mg/5 mL, 16 fl oz bottles (NDC 42192-619-16), Canadian-made, for chemical contamination by lead and lithium above specification, initiated 2026-04-20. The pediatric/liquid dosage form materially elevates the toxicological concern, particularly for chronic pediatric users.
• Not Yet Classified — B. Braun Medical is recalling Lactated Ringer's Injection USP, 1000 mL (NDC 0264-7750-07) for presence of particulate matter, initiated 2026-04-28. Pending classification, hospital pharmacies should treat as a particulate-injection risk and segregate affected lots from IV-room inventory.

Compounded and Specialty Products

• D-0524-2026 — Central Admixture Pharmacy Services (CAPS) Los Angeles is recalling a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) as Class II for incorrect formulation — product did not contain insulin as labeled, initiated 2025-12-27. The narrow distribution limits scope, but the case is a reminder that 503B/compounded TPN errors continue to surface months after distribution.

Impurity, Potency, and Specification Failures

• D-0520-2026 — JB Chemicals & Pharmaceuticals (Unique Pharmaceutical Laboratories, Mumbai), distributed by Rising Pharma Holdings, is recalling Enalapril Maleate Tablets USP 20 mg, 1000-count bottles, as Class II for an out-of-specification organic impurities result, initiated 2026-04-23.
• D-0511-2026 — Unichem Pharmaceuticals USA is recalling buspirone HCl tablets USP 5 mg, 500-count bottles, manufactured by Unichem Laboratories Ltd. (Ghaziabad, India), as Class III for subpotency, initiated 2026-04-13. Class III signals low patient-harm probability, but for an anxiolytic the breakthrough-symptom risk on subtherapeutic dosing is non-trivial.

Editorial Note

Today's docket reinforces two persistent supply-chain themes: nitrosamine-class impurities continue to surface in long-term stability data across multiple manufacturers and geographies, and Indian-manufactured finished doses remain disproportionately represented in CGMP-driven Class II actions. Procurement and P&T committees should treat the duloxetine cluster as a class-wide signal rather than three isolated firm events.