The FDA Desk — 2026-06-02

TITLE: FDA Desk — June 2: Class I Recall on MG217 Cream; Nitrosamine, Sterility, and Cross-Contamination Issues Dominate

Class I — Priority Action

• D-0553-2026: Wisconsin Pharmacal Company voluntarily recalled MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%, 6 oz, manufactured by Pharmacal of Jackson, WI) on 2026-04-24 after confirmed *Staphylococcus aureus* contamination — a microbial hazard in a non-sterile topical that warrants immediate pull from shelves and patient outreach, particularly for users with compromised skin barriers.

Class II — Sterility, Potency, and Nitrosamine Concerns

• D-0546-2026: UCB Biosciences recalled Cimzia (certolizumab pegol) 2x200 mg/mL prefilled syringes — including commercial, professional sample, and starter kit NDCs (50474-710-79/-80/-81) — on 2026-05-08 for lack of assurance of sterility, a notable risk in an injectable biologic used by immunosuppressed patients.
• D-0548-2026: IntegraDose Compounding Services (Shoreview, MN) recalled compounded fentanyl citrate sterile CADD injection, 2,250 mcg/50 mL (NDC 71139-6030-1) on 2026-05-12 as subpotent — a meaningful patient-safety concern given the product's use in pain-control infusions where dose accuracy is critical.
• D-0541-2026: Lupin Pharmaceuticals recalled liraglutide injection 18 mg/3 mL prefilled pens (NDCs 70748-346-02 and -03), manufactured in Nagpur, India, on 2026-04-24 after a white thread-like particulate was identified in cartridges — a visible foreign-matter defect in a chronic-use GLP-1 product.
• D-0544-2026 / D-0545-2026: Zydus Pharmaceuticals (USA) recalled erythromycin tablets USP at both 250 mg (NDC 70710-1047-3) and 500 mg (NDC 70710-1048-3) strengths on 2026-04-29, citing CGMP deviations and N-Nitroso-Desmethyl-Erythromycin levels above the recommended acceptable intake — the latest in the long-running nitrosamine impurity pattern affecting generic oral solids manufactured offshore.
• D-0538-2026: Safecor Health repackaged atomoxetine HCl capsules in unit-dose foil strips (NDC 64380-474-01) labeled as 10 mg but actually containing 25 mg — a 2.5x mislabel announced 2026-04-30 that creates real overdose exposure in pediatric ADHD patients titrated by milligram.

Class III — Primidone Cross-Contamination Cluster

A coordinated cross-contamination event traces back to Lannett Company API tainted with trace acemetacin, surfacing across three distributors:

• D-0537-2026: Amerisource Health Services / American Health Packaging recalled primidone 50 mg unit-dose blister cartons (NDC 68084-202-01; dose NDC 68084-202-11) on 2026-05-01.
• D-0534-2026 and D-0535-2026: Golden State Medical Supply (Camarillo, CA), marketing under GSMS, recalled primidone 50 mg, 50-count bottles (NDC 51407-637-05) and primidone 250 mg, 100-count bottles (NDC 51407-638-01) on 2026-04-27.

While Class III signals a low likelihood of adverse health consequences, the introduction of an NSAID-class API into an antiepileptic raises labeling-integrity and supplier-qualification questions for downstream pharmacies dispensing Lannett-sourced primidone.

Editorial Note

Today's docket reflects three persistent FDA enforcement themes: nitrosamine impurities in India-manufactured generics (Zydus), sterility assurance failures in both compounded and biologic injectables (IntegraDose, UCB), and API cross-contamination traceable to a single domestic manufacturer (Lannett). Pharmacy buyers should prioritize the MG217 Class I pull and the Safecor atomoxetine strength mix-up for immediate quarantine.