The FDA Desk — 2026-05-22

TITLE: FDA Desk — Nitrosamine sweep widens across duloxetine; heavy-metal contamination in pediatric naproxen

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Top Line

No Class I recalls were posted today. The day's docket is dominated by a multi-manufacturer N-nitroso-duloxetine problem and a pair of sterility actions affecting BD's PurPrep antiseptic applicators. One unclassified B. Braun IV fluid recall is also pending categorization and warrants monitoring.

Nitrosamine Impurity — Duloxetine DR Capsules

A coordinated cluster of Class II recalls landed today, all citing CGMP deviations tied to N-nitroso-duloxetine detected above the FDA-recommended 0.83 ppm limit during 12- and 18-month long-term stability testing. The breadth across unrelated manufacturers suggests an industry-wide stability/formation issue rather than a single-site failure.

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India), marketed by Ajanta Pharma USA, recalled Duloxetine DR Capsules 30 mg (90-, 30-, and 1000-count) and 20 mg (60-count); firm-initiated 2026-04-29.
• D-0522-2026 — Breckenridge Pharmaceutical recalled Duloxetine DR Capsules 60 mg (90-count), manufactured by Towa Pharmaceutical Europe in Spain; firm-initiated 2026-04-21. The presence of a Spain-manufactured product alongside India-sourced product reinforces that the impurity is not geographically isolated.

Dispensing pharmacies should expect downstream patient-level notifications and consider proactive lot reconciliation against the listed NDCs (27241-098-xx, 27241-097-06, 51991-748-90).

Chemical Contamination — Pediatric and Cardiovascular Drugs

• D-0523-2026 — Acella Pharmaceuticals recalled Naproxen Oral Suspension 125 mg/5 mL (473 mL bottles, NDC 42192-619-16, manufactured in Canada) as Class II for chemical contamination, specifically lead and lithium above specification. The pediatric-suspension dosage form elevates the clinical concern even at Class II; caregivers and pediatric prescribers should be alerted.
• D-0520-2026 — JB Chemicals & Pharmaceuticals (Unique Pharmaceutical Laboratories, Mumbai), distributed by Rising Pharma, recalled Enalapril Maleate Tablets USP 20 mg (1,000-count) as Class II for an out-of-specification organic impurities result.
• D-0511-2026 — Unichem Pharmaceuticals (USA) recalled buspirone HCl Tablets USP 5 mg (500-count) as Class III for subpotency. Class III signals low likelihood of adverse health consequence, but the therapeutic-window implications for anxiety management still warrant pharmacy-level lot checks.

Sterility and Compounding Errors

• D-0518-2026 and D-0517-2026 — CareFusion 213, LLC (a Becton Dickinson subsidiary, El Paso, TX) issued companion Class II recalls of BD PurPrep Povidone-iodine/IPA Sterile Solution applicators (10.5 mL and 26 mL configurations) for lack of assurance of sterility / potential contamination; firm-initiated 2026-04-22. The presence of a *preoperative skin antiseptic* on a sterility recall is clinically significant — affected lots should be sequestered from surgical and procedural areas immediately.
• D-0524-2026 — Central Admixture Pharmacy Services (CAPS) Los Angeles recalled a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) as Class II because the compounded product did not contain insulin as labeled. This is a single-patient compounding error rather than a market-wide event, but it underscores recurring CAPS labeling/formulation issues that institutional pharmacy directors should track.

Pending Classification — Monitor

• B. Braun Medical has voluntarily recalled Lactated Ringer's Injection USP, 1000 mL (NDC 0264-7750-07) for presence of particulate matter; FDA has not yet assigned a class. Given the IV route and the manufacturer's prior particulate-related actions, hospital pharmacy and supply chain teams should pre-position alternate LR sourcing pending classification.

Editorial Note

Today's docket is unusually concentrated on impurity and contamination chemistry — nitrosamines, heavy metals, organic impurities, and particulates — rather than labeling or device defects. The recurrence of N-nitroso-duloxetine across three sponsors and two continents suggests FDA may issue broader guidance on duloxetine stability specifications in the near term. Counsel advising generic sponsors should review stability protocols and supplier qualifications for amine-containing APIs proactively.