The FDA Desk — 2026-05-26

TITLE: FDA Desk — May 26: Class II sweep hits sterile preps, nitrosamine duloxetine, and a TPN missing insulin

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Today's Docket

No Class I recalls posted in today's FDA enforcement update. The day's activity is uniformly Class II, but several entries warrant clinical attention — particularly a patient-specific TPN bag dispensed without its labeled insulin, and renewed nitrosamine findings in duloxetine.

Compounding and Sterility Concerns

• D-0524-2026 — Central Admixture Pharmacy Services (CAPS) of Santa Fe Springs, CA recalled a patient-specific 1,660 mL TPN bag (Rx# 11-4909703-0-1) after determining the compounded product did not contain insulin as labeled, a formulation error with direct glycemic-control implications for the receiving patient.
• D-0525-2026 — OASIS Medical recalled Oasis Tears PF preservative-free lubricant eye drops (10 mL, NDC 42126-6400-1, manufactured in France by Excelvision) citing lack of assurance of sterility following FDA inspectional observations at the contract manufacturer; the firm characterizes the action as precautionary.
• D-0517-2026 and D-0518-2026 — CareFusion 213 (a Becton Dickinson subsidiary) recalled two BD PurPrep povidone-iodine/isopropyl alcohol skin-prep configurations (25-count applicator cartons in 10.5 mL and 26 mL sizes, NDC 54365-014-42) for potential contamination undermining sterility assurance of a pre-procedural antiseptic.

Impurities, Contamination, and CGMP Failures

• D-0514-2026 and D-0516-2026 — Ajanta Pharma recalled duloxetine delayed-release capsules in both 30 mg (NDCs 27241-098-09/-03/-10) and 20 mg (NDC 27241-097-06) strengths after 12- and 18-month long-term stability data showed N-nitroso-duloxetine exceeding FDA's 0.83 ppm limit, the latest in a series of nitrosamine actions across the SSRI/SNRI class.
• D-0523-2026 — Acella Pharmaceuticals recalled Naproxen Oral Suspension USP 125 mg/5 mL in 473 mL bottles (NDC 42192-619-16, made in Canada) after detecting lead and lithium above specification — a heavy-metal contamination finding in a pediatric-friendly liquid formulation that merits prescriber awareness.
• D-0527-2026 — Endo USA recalled Buprenorphine HCl Injection 0.3 mg/mL in 5x1 mL single-dose vials (NDC 42023-179-05) due to visible particulate matter identified as buprenorphine free base precipitating out of solution.
• D-0520-2026 — Rising Pharma's Enalapril Maleate Tablets USP 20 mg in 1,000-count bottles, manufactured by Unique Pharmaceutical Laboratories (JB Chemicals, Mumbai), were recalled for out-of-specification organic impurity results.

Performance and Dissolution

• D-0547-2026 — Ascend Laboratories recalled Metoprolol Succinate Extended-Release Tablets USP 25 mg (NDC 67877-590-01, manufactured by Alkem Laboratories, India) for failed dissolution specifications, raising the prospect of altered release kinetics in a chronically dosed cardiovascular product.

Editor's Note

Today's slate shows two recurring themes worth tracking: nitrosamine stability failures continuing to surface at the 12–18-month interval (Ajanta's duloxetine), and contract-manufacturer sterility lapses propagating into U.S.-labeled products (Excelvision/OASIS, Alkem/Ascend, JB Chemicals/Rising). The CAPS TPN error is isolated but a reminder that compounded sterile preparations remain a single-patient harm vector distinct from mass-manufactured recalls.