The FDA Desk — 2026-06-03

TITLE: FDA Desk — Class I recall of MG217 skin cream; nitrosamine and sterility issues drive Class II actions

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Class I — Immediate Risk

• D-0553-2026 — Wisconsin Pharmacal Company initiated a Class I voluntary recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%, 6 oz, manufactured by Pharmacal, Jackson, WI) after confirmed microbial contamination with *Staphylococcus aureus* — a meaningful infection risk for users applying the product to compromised psoriatic or eczematous skin.

Class II — Sterility, Potency, and Nitrosamine Concerns

Sterility and particulate matter

• D-0546-2026 — UCB Biosciences recalled Cimzia (certolizumab pegol) 2x200 mg/mL prefilled syringes (commercial, professional sample, and Starter Kit NDCs 50474-710-79/-80/-81) for lack of assurance of sterility — a notable concern given the immunosuppressed Cimzia patient population.
• D-0541-2026 — Lupin Pharmaceuticals recalled Liraglutide Injection 18 mg/3 mL pens (NDCs 70748-346-02 and -03) after a white thread-like particulate was identified inside the cartridge, raising injection-site and embolic risk concerns for the GLP-1 product.
• D-0548-2026 — IntegraDose Compounding Services (Shoreview, MN) recalled compounded fentanyl citrate sterile CADD for injection, 2,500 mcg/50 mL (NDC 71139-6030-1) as subpotent — clinically significant for opioid-tolerant infusion patients who may experience uncontrolled pain or withdrawal.

Nitrosamine impurity — Zydus erythromycin

• D-0544-2026 / D-0545-2026 — Zydus Pharmaceuticals (USA), distributing for Zydus Lifesciences (Ahmedabad), recalled Erythromycin Tablets USP 250 mg and 500 mg (NDCs 70710-1047-3 and 70710-1048-3) for CGMP deviations and presence of N-nitroso-desmethyl-erythromycin above the recommended acceptable intake limit, continuing the broader nitrosamine impurity pattern affecting older small-molecule APIs.

Labeling mix-up

• D-0538-2026 — Safecor Health (Columbus, OH) recalled unit-dose atomoxetine HCl capsules labeled as 10 mg but actually containing 25 mg strength — a 2.5x overdose risk for pediatric and adult ADHD patients titrated on label strength.

Class III — Cross-Contamination in Primidone Supply

Three concurrent Class III recalls trace to a shared API problem: primidone API contaminated with trace Acemetacin (an NSAID not approved in the U.S.). Affected lots span multiple packagers of Lannett-manufactured tablets:

• D-0537-2026 — American Health Packaging (Columbus, OH) Primidone 50 mg 100-count unit-dose cartons (NDC 68084-202-01).
• D-0534-2026 — GSMS / Golden State Medical Supply Primidone 50 mg 50-count bottles (NDC 51407-637-05).
• D-0535-2026 — GSMS / Golden State Medical Supply Primidone 250 mg 100-count bottles (NDC 51407-638-01).

While Class III signals a low likelihood of adverse health consequences, prescribers managing epilepsy patients on primidone should be aware of the NSAID cross-contamination given potential GI, renal, and bleeding sensitivities in chronic neurology populations.

Editor's Note

Today's docket is dominated by manufacturing quality failures rather than clinical safety signals — sterility assurance (Cimzia, compounded fentanyl), particulate (Lupin liraglutide), nitrosamine impurities (Zydus erythromycin), and API cross-contamination (Lannett primidone). The Pharmacal-manufactured MG217 cream is the lone Class I action and the only consumer-facing OTC product in the set.