The FDA Desk — 2026-06-01

TITLE: FDA Desk — June 1: Ten Class II recalls span sterility failures, nitrosamine impurities, and heavy-metal contamination

---

FDA Recalls — June 1, 2026

No Class I recalls posted today. Ten Class II actions, all firm-initiated, cluster around three recurring themes: sterility assurance failures at contract manufacturers, nitrosamine and impurity findings in oral solids, and isolated but serious compounding and contamination events.

Sterility assurance failures

• D-0518-2026 and D-0517-2026 — CareFusion 213, LLC (a Becton Dickinson subsidiary, El Paso, TX) is recalling BD PurPrep povidone-iodine/isopropyl alcohol applicators (10.5 mL and 26 mL configurations) for lack of sterility assurance and potential product contamination; 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, made in France by Excelvision) out of an abundance of caution following FDA inspectional observations at the French manufacturing site; initiated 2026-04-27.

Nitrosamine, impurity, and dissolution failures in oral solids

• D-0514-2026 and D-0516-2026 — Ajanta Pharma Ltd. (India), via Ajanta Pharma USA (Bridgewater, NJ), is recalling Duloxetine Delayed-Release Capsules at both 30 mg (90-, 30-, and 1000-count) and 20 mg (60-count) strengths after 12- and 18-month long-term stability testing showed N-nitroso-duloxetine above the FDA-recommended 0.83 ppm limit — a CGMP deviation flagged 2026-04-29.
• D-0520-2026 — JB Chemicals & Pharmaceuticals Ltd. (Mumbai), distributed in the U.S. by Rising Pharma Holdings, is recalling Enalapril Maleate Tablets USP 20 mg (1,000-count) for an out-of-specification organic impurities 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 recall with direct cardiovascular-therapy implications; initiated 2026-04-27.

Contamination and formulation errors

• D-0523-2026 — Acella Pharmaceuticals, LLC (Alpharetta, GA), distributing Canadian-made Naproxen Oral Suspension USP 125 mg/5 mL (16 fl oz bottles, NDC 42192-619-16), is recalling product for chemical contamination — lead and lithium above specification — a particularly concerning finding in a pediatric-friendly liquid dosage form; initiated 2026-04-20.
• D-0527-2026 — Endo USA, Inc. (Malvern, PA) is recalling Buprenorphine Hydrochloride Injection 0.3 mg/mL (5×1 mL single-dose vials, NDC 42023-179-05) for visible particulate matter identified as buprenorphine free base; initiated 2026-03-13.
• 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) that did not contain insulin as labeled — an incorrect-formulation event with direct patient-harm potential in a single-dose parenteral nutrition product; initiated 2025-12-27.

Editorial note

Today's docket is notable less for any single event than for the pattern: three of ten actions involve impurity or contamination findings in Indian- or Canadian-sourced oral products (duloxetine, enalapril, naproxen), and three involve sterility or particulate concerns at U.S. and French facilities. The CAPS TPN mislabeling and the Acella heavy-metal finding warrant the closest pharmacy and prescriber attention despite the Class II designation.