The FDA Desk — 2026-05-30

TITLE: FDA Desk — May 30: Class II recalls span sterility failures, nitrosamine impurities, and a TPN insulin omission

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Editor's Note

No Class I recalls posted today. The day's docket is entirely Class II, voluntary firm-initiated actions, but several warrant clinician attention — particularly a compounded TPN bag dispensed without labeled insulin, lead and lithium contamination in a pediatric-relevant naproxen suspension, and recurring N-nitroso-duloxetine findings.

Sterility & Contamination

• D-0524-2026: Central Admixture Pharmacy Services (CAPS) Los Angeles recalled a patient-specific TPN bag (Rx# 11-4909703-0-1, 1,660 mL) after the compounded product was found to contain no insulin despite labeling — a formulation error with clear glycemic-management implications for the receiving patient.
• D-0523-2026: Acella Pharmaceuticals' Naproxen Oral Suspension USP 125 mg/5 mL (16 fl oz bottles, NDC 42192-619-16) was recalled for chemical contamination — lead and lithium detected above specification — raising particular concern given the suspension's frequent pediatric use.
• D-0518-2026 / D-0517-2026: CareFusion 213 (a Becton Dickinson subsidiary) pulled two BD PurPrep povidone-iodine/isopropyl alcohol skin-prep configurations (10.5 mL and 26 mL applicator cartons) on April 22 for potential contamination undermining sterility assurance — clinically significant given pre-procedural antiseptic use.
• D-0525-2026: Oasis Medical recalled Oasis Tears PF Preservative-Free Lubricant Eye Drops (10 mL, NDC 42126-6400-1, made in France by Excelvision) out of an abundance of caution following FDA inspection observations at the French manufacturer affecting sterility assurance.

Impurities & Nitrosamines

• D-0514-2026 and D-0516-2026: Ajanta Pharma Ltd. recalled Duloxetine Delayed-Release Capsules in both 30 mg (multiple count sizes, NDC 27241-098-xx) and 20 mg (60-count, NDC 27241-097-06) presentations after 12- and 18-month long-term stability testing showed N-nitroso-duloxetine impurity exceeding the FDA-recommended 0.83 ppm limit — the latest in an ongoing wave of nitrosamine-driven CGMP recalls.
• D-0520-2026: JB Chemicals & Pharmaceuticals (Unique Pharmaceutical Laboratories, Mumbai), distributed by Rising Pharma Holdings, recalled Enalapril Maleate Tablets USP 20 mg in 1,000-count bottles for an out-of-specification organic impurities result on degradation testing.
• D-0527-2026: Endo USA recalled Buprenorphine Hydrochloride Injection 0.3 mg/mL (5 × 1 mL single-dose vials, NDC 42023-179-05) after particulate matter — identified as buprenorphine free base — was detected, posing embolic and inflammatory risk on parenteral administration.

Performance & 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 — a release-rate failure with direct implications for heart-failure and hypertension dose control.

Takeaways for Counsel and Clinicians

Today's docket reinforces two persistent themes: (1) foreign-manufactured generics continue to drive nitrosamine and impurity recalls under CGMP scrutiny, and (2) sterility-assurance failures at upstream contract manufacturers (Excelvision, CareFusion's El Paso site) propagate across multiple distributor labels. The CAPS TPN error is the day's most acute single-patient hazard and a reminder that 503A/503B compounding remains a focal point for formulation-verification litigation.