The FDA Desk — 2026-06-04

TITLE: FDA Desk — Class I Recall on MG217 Cream; Nitrosamine Findings Pull Zydus Erythromycin

---

Class I — Highest Priority

• D-0553-2026: Wisconsin Pharmacal Company is recalling MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%, 6 oz) after confirmed *Staphylococcus aureus* contamination of the non-sterile product — a firm-initiated action posing serious infection risk for users applying to compromised or psoriatic skin.

Class II — Identity, Sterility, and Nitrosamine Concerns

• D-0538-2026: Safecor Health is recalling unit-dose Atomoxetine HCl 10 mg capsules (NDC 64380-474-01) after a label mix-up in which 25 mg capsules were packaged as 10 mg — a 2.5× overdose risk for ADHD patients, including pediatric users.
• D-0545-2026 / D-0544-2026: Zydus Pharmaceuticals (USA) is recalling Erythromycin Tablets USP 250 mg and 500 mg (NDCs 70710-1047-3 and 70710-1048-3), manufactured by Zydus Lifesciences in India, after CGMP deviations led to *N-Nitroso-Desmethyl-Erythromycin* levels above the acceptable intake limit — the latest in an ongoing wave of nitrosamine impurity actions.
• D-0546-2026: UCB Biosciences is recalling Cimzia (certolizumab pegol) 2×200 mg/mL prefilled syringes, including professional samples and starter kits, for lack of assurance of sterility — a material concern for an immunosuppressive biologic administered to patients with rheumatoid arthritis, Crohn's, and psoriatic disease.
• D-0548-2026: IntegraDose Compounding Services is recalling compounded fentaNYL Citrate Sterile CADD for Injection, 2,250 mcg/50 mL (NDC 71139-6030-1) as subpotent — clinically significant for opioid-tolerant inpatients relying on accurate continuous infusion dosing.
• D-0541-2026: Lupin Pharmaceuticals is recalling Liraglutide Injection 18 mg/3 mL pen cartridges (NDCs 70748-346-02/-03) after a white, thread-like particulate was identified in cartridges manufactured by Lupin Limited (Nagpur, India) — raising injection-site and embolic concerns for diabetes and weight-management patients.

Class III — Cross-Contamination in Primidone Supply

A coordinated set of firm-initiated recalls points to upstream API cross-contamination at Lannett Company, where Primidone Tablets USP are showing trace Acemetacin API (an NSAID not approved in the U.S.).

• D-0534-2026 and D-0535-2026: Golden State Medical Supply is recalling Primidone 50 mg (50-count, NDC 51407-637-05) and Primidone 250 mg (100-count, NDC 51407-638-01), both manufactured by Lannett and marketed by GSMS.
• D-0537-2026: Amerisource Health Services (Amerisource Health Packaging) is recalling Primidone 50 mg unit-dose blister cartons (carton NDC 68084-202-01) for the same cross-contamination defect — relevant for epilepsy patients on chronic therapy.

Editor's Note

The Primidone cluster suggests a single API-level event at the manufacturer rippling across distributors; expect additional lots and labelers to follow. The Zydus erythromycin nitrosamine findings extend the regulatory pattern that began with sartans and ranitidine into the macrolide class, and the Cimzia sterility action is the most commercially consequential item for specialty pharmacies today.