The FDA Desk — 2026-05-27
TITLE: FDA Desk — May 27: Ten Class II Recalls Span Sterility, Nitrosamine, and Heavy-Metal Failures
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Summary
Today's enforcement report from FDA contains ten recalls, all Class II (reasonable probability of temporary or medically reversible adverse consequences; remote probability of serious harm). No Class I actions were posted. The dominant themes are sterility assurance failures, nitrosamine impurity findings in duloxetine, and a notable heavy-metal contamination in a pediatric-relevant oral suspension. All actions are firm-initiated voluntary recalls.
Sterility and Contamination
- D-0518-2026 / D-0517-2026 — CareFusion 213, a Becton Dickinson subsidiary, is recalling two configurations of BD PurPrep povidone-iodine/isopropyl alcohol skin prep applicators (10.5 mL single-applicator boxes and 26 mL applicator cartons, NDC 54365-014-42) for lack of assurance of sterility and potential contamination — a meaningful exposure given pre-procedural skin antisepsis use.
- D-0525-2026 — Oasis Medical is recalling 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. Ophthalmic sterility failures historically warrant close monitoring even at Class II.
- D-0524-2026 — Central Admixture Pharmacy Services (CAPS) Los Angeles is recalling a patient-specific TPN bag (Rx# 11-4909703-0-1, 1,660 mL) because the compounded product did not contain insulin as labeled — a compounding error with direct dosing implications, dated back to 2025-12-27.
Nitrosamines and Impurities
- D-0514-2026 / D-0516-2026 — Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules in 30 mg (multiple counts including 1,000-count institutional bottles, NDC 27241-098-xx) and 20 mg (60-count, NDC 27241-097-06) for N-nitroso-duloxetine impurity exceeding the FDA recommended 0.83 ppm limit at 12- and 18-month stability intervals — continuing the broader nitrosamine remediation trend across generic SSRIs/SNRIs.
- D-0520-2026 — JB Chemicals & Pharmaceuticals (Unique Pharmaceutical Labs, Mumbai), distributed by Rising Pharma, is recalling 20 mg Enalapril Maleate Tablets (1,000-count bottles) for out-of-specification organic impurities — a hypertension/heart-failure mainstay where supply continuity will matter for pharmacists.
- D-0527-2026 — Endo USA is recalling Buprenorphine HCl Injection 0.3 mg/mL (5×1 mL single-dose vials, NDC 42023-179-05) due to visible particulate matter identified as buprenorphine free base. Parenteral particulates in a controlled-substance analgesic raise both safety and chain-of-custody handling concerns.
Performance and Composition Failures
- D-0547-2026 — Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg (NDC 67877-590-01), manufactured by Alkem Laboratories (India), for failed dissolution specifications — potentially clinically significant given the ER formulation's role in rate control and post-MI management.
- D-0523-2026 — Acella Pharmaceuticals is recalling Naproxen Oral Suspension 125 mg/5 mL (16 fl oz bottles, NDC 42192-619-16, made in Canada) for chemical contamination with lead and lithium above specification. Given that oral naproxen suspensions are commonly dispensed for pediatric and dysphagic patients, this is the day's most clinically concerning Class II — heavy-metal exposure warrants prompt pharmacy quarantine and patient notification.
Editor's Note
Today's docket is unusually weighted toward upstream manufacturing failures at offshore facilities (India, France, Canada) reaching U.S. patients through domestic distributors. The Acella naproxen heavy-metal finding and the CAPS insulin-omission compounding error are the items most likely to draw plaintiffs' attention; the Ajanta duloxetine actions extend the nitrosamine docket that has now persisted across multiple product classes for more than five years.