The FDA Desk — 2026-05-31

TITLE: FDA Desk — May 31, 2026: Class II Sweep Spans Sterility, Nitrosamines, and Heavy-Metal Contamination

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Summary

No Class I recalls posted today. The FDA's recall feed today is dominated by ten Class II actions, all firm-initiated, clustering around three recurring failure modes: sterility assurance lapses traced to recent FDA inspections, nitrosamine and heavy-metal impurity findings in generic oral drugs, and isolated compounding/formulation errors. Several entries point to upstream foreign-manufacturer CGMP issues (India, Canada, France) flowing through U.S. distributors.

Sterility Assurance Failures

• D-0518-2026 and D-0517-2026 — CareFusion 213, LLC (a Becton Dickinson subsidiary, El Paso, TX) recalled two presentations of BD PurPrep povidone-iodine/isopropyl alcohol sterile applicators (10.5 mL and 26 mL configurations) on 2026-04-22 for lack of sterility assurance and potential contamination — a notable signal given PurPrep's widespread perioperative use.
• D-0525-2026 — Oasis Medical, Inc. (Glendora, CA) recalled Oasis Tears PF preservative-free lubricant eye drops (10 mL, NDC 42126-6400-1), manufactured in France by Excelvision, on 2026-04-27 out of an abundance of caution following adverse FDA observations during an Excelvision inspection. Ophthalmic sterility failures warrant heightened attention given the FDA's recent enforcement posture on imported eye drops.

Nitrosamine and Heavy-Metal Impurities

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India), through Ajanta Pharma USA (Bridgewater, NJ), recalled multiple configurations of Duloxetine Delayed-Release Capsules at 30 mg (90-, 30-, and 1000-count) and 20 mg (60-count) on 2026-04-29 after N-nitroso-duloxetine was detected above the FDA recommended 0.83 ppm limit at the 12- and 18-month long-term stability intervals — extending the industry-wide nitrosamine problem deeper into the SNRI class.
• D-0523-2026 — Acella Pharmaceuticals, LLC (Alpharetta, GA) recalled Naproxen Oral Suspension USP, 125 mg/5 mL, 473 mL bottles (NDC 42192-619-16), made in Canada, on 2026-04-20 for chemical contamination with lead and lithium above specification — a pediatric-relevant concern given the suspension dosage form.
• D-0520-2026 — JB Chemicals & Pharmaceuticals Ltd. (Mumbai), distributed through Rising Pharma Holdings, recalled Enalapril Maleate Tablets USP 20 mg in 1,000-count bottles on 2026-04-23 for failed organic-impurities/degradation specifications.

Other CGMP and Quality Failures

• D-0547-2026 — Ascend Laboratories, LLC (Parsippany, NJ), with API/finished product from Alkem Laboratories Ltd. (India), recalled Metoprolol Succinate Extended-Release Tablets USP 25 mg (NDC 67877-590-01) on 2026-04-27 for failed dissolution specifications — a clinically meaningful defect for a rate-controlled cardiovascular drug.
• D-0527-2026 — Endo USA, Inc. (Malvern, PA) recalled Buprenorphine Hydrochloride Injection 0.3 mg/mL in 5×1 mL single-dose vials (NDC 42023-179-05) on 2026-03-13 after particulate matter, identified as buprenorphine free base, was found in the product — a precipitation/formulation-stability signal in a controlled-substance parenteral.

Compounding Error

• D-0524-2026 — Central Admixture Pharmacy Services (CAPS), Los Angeles facility (Santa Fe Springs, CA) recalled a patient-specific TPN bag (Rx# 11-4909703-0-1, 1660 mL) on 2025-12-27 because the formulation omitted insulin listed on the label. Although a single-patient compounded product, the misformulation is reportable and underscores ongoing oversight of 503A/503B parenteral nutrition workflows.

Editor's Note

Today's slate is unusually concentrated in foreign-manufactured generics (India and Canada predominantly) reaching the U.S. market through domestic distributors, and in sterility findings traceable to FDA inspections rather than complaint-driven discovery. Counsel for affected distributors should expect downstream 483/Warning Letter exposure for the upstream manufacturers (Excelvision, Alkem, Ajanta, JB Chemicals, Unique Pharmaceutical Laboratories) and should review indemnification and recall-cost allocation provisions in their supply agreements.