The FDA Desk — 2026-05-28

TITLE: FDA Desk — May 28: Ten Class II recalls span sterility failures, nitrosamine impurities, and heavy-metal contamination

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Today's Enforcement Report posting carries ten Class II recalls and no Class I actions. The dominant themes are sterility assurance failures at contract manufacturing sites, nitrosamine and heavy-metal contamination of finished oral drugs, and a notable compounding-pharmacy formulation error involving omitted insulin in a patient-specific TPN bag.

Sterility and contamination concerns

• D-0518-2026 and D-0517-2026 cover two presentations of BD PurPrep povidone-iodine/isopropyl alcohol surgical prep applicators (10.5 mL and 26 mL) recalled by CareFusion 213, LLC, a Becton Dickinson subsidiary, on 2026-04-22 for lack of sterility assurance and potential product contamination — a recurring concern for skin antiseptics used in invasive procedures.
• D-0525-2026 — Oasis Medical recalled Oasis Tears PF preservative-free lubricant eye drops (10 mL bottles, made in France by Excelvision) on 2026-04-27 out of an abundance of caution following adverse FDA inspection observations at the contract manufacturer; ophthalmic sterility failures have driven Class I actions elsewhere in this category.
• D-0524-2026 — Central Admixture Pharmacy Services (CAPS) Los Angeles recalled a patient-specific 1,660 mL TPN bag (Rx# 11-4909703-0-1) on 2025-12-27 after it was compounded without insulin despite labeling indicating its presence — a compounding-pharmacy formulation error with direct dosing consequences for the named patient.

Nitrosamine and impurity failures in oral solids

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. recalled Duloxetine Delayed-Release Capsules in 20 mg (60-count) and 30 mg (30/90/1000-count) strengths, distributed in the U.S. by Ajanta Pharma USA, on 2026-04-29 after 12- and 18-month long-term stability testing showed N-nitroso-duloxetine above the FDA-recommended 0.83 ppm limit — extending the industry-wide nitrosamine problem to another SSNRI.
• D-0520-2026 — JB Chemicals and Pharmaceuticals Ltd. (manufacturing at Unique Pharmaceutical Laboratories, Mumbai) recalled Enalapril Maleate Tablets USP 20 mg in 1,000-count bottles, distributed by Rising Pharma Holdings, on 2026-04-23 for an out-of-specification organic impurities result.
• D-0547-2026 — Ascend Laboratories recalled Metoprolol Succinate Extended-Release Tablets USP 25 mg (manufactured by Alkem Laboratories, India) on 2026-04-27 for failed dissolution specifications, a bioavailability concern for a beta-blocker used in chronic cardiovascular dosing.
• D-0527-2026 — Endo USA recalled Buprenorphine Hydrochloride Injection 0.3 mg/mL (5×1 mL single-dose vials) on 2026-03-13 for visible particulate matter identified as buprenorphine free base — a parenteral particulate risk in a controlled-substance analgesic.

Heavy-metal contamination

• D-0523-2026 — Acella Pharmaceuticals recalled Naproxen Oral Suspension USP 125 mg/5 mL in 16 fl oz bottles (made in Canada) on 2026-04-20 after testing identified lead and lithium above specification — a notable elemental-impurity finding for a pediatric-friendly liquid NSAID dosage form that warrants attention from prescribers and dispensers.

Editorial note

No Class I or Class III actions appear in today's posting. The clustering of contract-manufacturing sterility failures (Excelvision, CareFusion El Paso) and India-sourced API/finished-dose quality deviations (Ajanta, Alkem, Unique/JB) is consistent with recent FDA inspectional trends and continues to favor enforcement attention on offshore CGMP compliance and stability-program rigor for nitrosamine cohorts.