The FDA Desk — 2026-05-29

TITLE: The FDA Desk — May 29, 2026: Ten Class II Recalls Span Sterility, Impurities, and a TPN Compounding Error

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Today's Recall Summary

No Class I recalls posted today. All ten entries are Class II, firm-initiated voluntary recalls, clustered around three failure modes: sterility assurance lapses, chemical/nitrosamine impurities, and a pharmacy compounding error involving a patient-specific TPN bag.

Sterility & Contamination

• 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 skin antiseptic applicators (10.5 mL boxes and 26 mL cartons, NDC 54365-014-42) for lack of sterility assurance due to potential product contamination; recalls initiated 2026-04-22.
• D-0525-2026 — Oasis Medical, Inc. (Glendora, CA) is recalling Oasis Tears PF Preservative-Free Lubricant Eye Drops (10 mL, NDC 42126-6400-1, manufactured in France by Excelvision) for lack of sterility assurance, initiated 2026-04-27 out of an abundance of caution following FDA inspectional observations at the Excelvision facility.

Impurities, Degradation & Chemical Contamination

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India), marketed by Ajanta Pharma USA (Bridgewater, NJ), is recalling 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 testing showed N-nitroso-duloxetine above the FDA recommended 0.83 ppm limit — a nitrosamine CGMP deviation; initiated 2026-04-29.
• D-0523-2026 — Acella Pharmaceuticals, LLC (Alpharetta, GA) is recalling Naproxen Oral Suspension USP, 125 mg/5 mL (473 mL bottles, NDC 42192-619-16, made in Canada) for chemical contamination with lead and lithium above specification — a notable heavy-metal finding in a pediatric-relevant liquid formulation; initiated 2026-04-20.
• D-0527-2026 — Endo USA (Malvern, PA) is recalling Buprenorphine Hydrochloride Injection 0.3 mg/mL (5×1 mL single-dose vials, NDC 42023-179-05) for particulate matter identified as buprenorphine free base, a precipitation/degradation defect in an injectable controlled substance; initiated 2026-03-13.
• D-0520-2026 — JB Chemicals & Pharmaceuticals Ltd. (Unique Pharmaceutical Laboratories, Mumbai), distributed by Rising Pharma Holdings, is recalling Enalapril Maleate Tablets USP 20 mg (1,000-count bottles) for an out-of-specification organic impurities/degradation result; initiated 2026-04-23.
• D-0547-2026 — Ascend Laboratories, LLC (Parsippany, NJ), with product manufactured by Alkem Laboratories (India), is recalling Metoprolol Succinate Extended-Release Tablets USP 25 mg (NDC 67877-590-01) for failed dissolution specifications — a release-rate failure with direct clinical implications for a rate-controlled cardiovascular drug; initiated 2026-04-27.

Compounding Error

• D-0524-2026 — Central Admixture Pharmacy Services (CAPS), Los Angeles facility (Santa Fe Springs, CA) is recalling a patient-specific TPN bag (Rx# 11-4909703-0-1, 1,660 mL compounded volume) because the formulation did not contain insulin as labeled — an incorrect-formulation event with significant glycemic-management risk; initiated 2025-12-27 and posted today.

Editorial Note

The day's docket is unusually weighted toward upstream manufacturing failures at foreign facilities — three of the ten recalls trace to India-made API or finished product (Ajanta ×2, Alkem/Ascend, JB Chemicals), and the Oasis Tears recall stems from FDA observations at France's Excelvision site. Combined with the BD PurPrep sterility recalls, the pattern reinforces continued FDA scrutiny of foreign-sourced sterile and oral solid-dose manufacturing. The CAPS TPN error stands apart as a domestic 503B-style compounding miss and warrants separate root-cause attention.