The FDA Desk — 2026-05-20
TITLE: FDA Desk — May 20, 2026: Nitrosamine impurity sweeps duloxetine; sterility failures hit BD PurPrep
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Top line
No Class I actions today. The day's docket is dominated by Class II pharmaceutical recalls, with three distinct duloxetine recalls converging on the same N-nitroso-duloxetine impurity problem, two BD PurPrep antiseptic lots pulled for sterility-assurance failures, and a notable chemical-contamination recall of pediatric-relevant naproxen oral suspension for lead and lithium.
Nitrosamine cluster: duloxetine
Three separately initiated recalls landed today around the same root cause — N-nitroso-duloxetine impurity exceeding the FDA's 0.83 ppm recommended limit, detected at 12- and 18-month long-term stability intervals — suggesting a stability-driven, not release-driven, defect pattern across multiple finished-dose manufacturers.
- D-0514-2026 and D-0516-2026 (Ajanta Pharma Ltd., made in India; marketed by Ajanta Pharma USA) cover duloxetine DR capsules 30 mg (90-, 30-, and 1000-count, NDC 27241-098 series) and 20 mg 60-count (NDC 27241-097-06), both classified Class II on 2026-04-29 for CGMP deviations tied to the nitrosamine finding.
- D-0522-2026 (Breckenridge Pharmaceutical, Inc.; mfr. Towa Pharmaceutical Europe S.L., Spain) recalls duloxetine DR capsules 60 mg, 90-count (NDC 51991-748-90), Class II, 2026-04-21 — same impurity, different supply chain, indicating the issue is not isolated to one API source.
Antiseptic sterility failures: BD PurPrep
CareFusion 213, LLC (a Becton Dickinson subsidiary, El Paso, TX) initiated parallel Class II recalls of BD PurPrep povidone-iodine 8.3% / isopropyl alcohol 72.5% sterile applicators for "lack of assurance of sterility" — a material concern given the product's pre-procedural skin prep indication.
- D-0518-2026 covers the 0.36 fl oz (10.5 mL) x 25 applicators/box configuration; D-0517-2026 covers the 26 mL applicator carton (NDC 54365-014-42). Both classified 2026-04-22.
Other drug-quality recalls
- D-0523-2026 — Acella Pharmaceuticals, LLC recalled naproxen oral suspension USP 125 mg/5 mL, 473 mL bottles (NDC 42192-619-16, made in Canada), Class II, 2026-04-20, for chemical contamination with lead and lithium above specification. Heavy-metal contamination in a liquid pediatric-dosable formulation warrants prescriber attention.
- D-0524-2026 — Central Admixture Pharmacy Services (CAPS) Los Angeles recalled a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) because the compounded product did not contain insulin as labeled; Class II, 2025-12-27. Single-patient compounding error, but illustrative of admixture labeling-vs-content reconciliation risk.
- D-0520-2026 — JB Chemicals & Pharmaceuticals Ltd. (Unique Pharmaceutical Laboratories div., Mumbai; distributed by Rising Pharma Holdings) recalled enalapril maleate tablets USP 20 mg, 1,000-count, Class II, 2026-04-23, for an out-of-specification organic impurities result.
- D-0511-2026 — Unichem Pharmaceuticals USA Inc. recalled buspirone HCl tablets USP 5 mg, 500-count (mfr. Unichem Laboratories Ltd., Ghaziabad, India), Class III, 2026-04-13, for subpotency. Class III reflects unlikely adverse health consequences, but prescribers should note potential under-treatment.
Unclassified / pending
- B. Braun Medical Inc. initiated a voluntary recall of Lactated Ringer's Injection USP, 1000 mL (NDC 0264-7750-07) on 2026-04-28 for particulate matter. Classification is not yet assigned; given the IV route and large-volume parenteral use, particulates would typically support a Class II or higher determination once finalized.
Editor's note
The recurring duloxetine N-nitroso impurity signal across unrelated manufacturers (Ajanta, Towa/Breckenridge) and the recent broader nitrosamine enforcement posture suggest health systems should review duloxetine sourcing and consider lot-level reconciliation rather than treating these as isolated firm events.