The FDA Desk — 2026-05-25

TITLE: FDA Desk — May 25: Nitrosamine recalls widen across duloxetine; sterility and contamination actions hit IV and antiseptic supplies

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No Class I recalls were posted today. The day's docket is dominated by Class II actions concentrated in three areas: nitrosamine impurities in duloxetine, sterility and contamination concerns in injectables and antiseptics, and assorted CGMP failures in oral solids.

Nitrosamine Impurities — Duloxetine Cluster

Three separate duloxetine recalls posted today extend the ongoing industry-wide N-nitroso-duloxetine problem, with impurity levels exceeding FDA's 0.83 ppm recommended limit detected at 12- and 18-month stability intervals.

• D-0514-2026 and D-0516-2026: Ajanta Pharma Ltd. (India), marketed in the U.S. by Ajanta Pharma USA, is recalling Duloxetine Delayed-Release Capsules in 30 mg (NDC 27241-098, 30/90/1000-count) and 20 mg (NDC 27241-097-06, 60-count) presentations for CGMP deviations tied to nitrosamine formation on long-term stability.
• D-0522-2026: Breckenridge Pharmaceutical is recalling 60 mg Duloxetine DR Capsules (NDC 51991-748-90, 90-count), manufactured by Towa Pharmaceutical Europe in Spain, for the same N-nitroso-duloxetine exceedance — signaling the impurity is not isolated to a single API source.

Sterility and Contamination — Injectables and Antiseptics

• 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/isopropyl alcohol sterile applicators (10.5 mL single applicators and 26 mL applicators, NDC 54365-014-42) for lack of assurance of sterility and potential product contamination — a notable concern given PurPrep's routine use in preoperative skin antisepsis.
• Not Yet Classified: B. Braun Medical is recalling Lactated Ringer's Injection USP, 1000 mL bags (NDC 0264-7750-07), for presence of particulate matter. Classification is pending but the action warrants immediate stock review at hospital pharmacies given LR's high-volume use.
• D-0524-2026: Central Admixture Pharmacy Services (CAPS) Los Angeles is recalling a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) because the compounded product did not contain insulin despite being labeled to include it — a single-patient error, but an instructive reminder of compounding-label fidelity risk.

Impurity and Potency Failures — Oral Solids

• D-0523-2026: Acella Pharmaceuticals is recalling Naproxen Oral Suspension USP, 125 mg/5 mL, 473 mL bottles (NDC 42192-619-16), manufactured in Canada, after lead and lithium were detected above specification — a chemical contamination finding of particular concern for a pediatric-friendly liquid dosage form.
• D-0520-2026: Rising Pharma Holdings is recalling Enalapril Maleate Tablets USP, 20 mg, 1,000-count bottles, manufactured by JB Chemicals' Unique Pharmaceutical Laboratories division (Mumbai), after an out-of-specification result in the organic impurities test.
• D-0511-2026: Unichem Pharmaceuticals (USA) is recalling Buspirone HCl Tablets USP, 5 mg, 500-count bottles, manufactured in Ghaziabad, India, as a Class III action for subpotency — lower clinical risk but a dispensing-substitution consideration for chronic anxiety patients.

Editorial Note

Today's docket reinforces two themes regulators and counsel should be tracking: (1) the duloxetine nitrosamine issue is now a multi-manufacturer, multi-continent pattern rather than a single-supplier defect, suggesting forthcoming FDA guidance or warning-letter activity on API process controls; and (2) sterile and high-volume injectable supply remains fragile, with another major antiseptic and another large-volume IV fluid pulled in the same news cycle.