The FDA Desk — 2026-06-05

TITLE: FDA Desk — June 5, 2026: Class I Recall of MG217 Cream; Nitrosamine Findings in Zydus Erythromycin

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Class I — Immediate Hazard

• D-0553-2026: Wisconsin Pharmacal Company is recalling MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%, 6 oz) after confirmed microbial contamination with *Staphylococcus aureus*. The firm-initiated action posted 2026-04-24 reflects the highest-tier risk classification, given the product's use on compromised skin in psoriasis and eczema patients.

Class II — Drug Quality and Sterility

Nitrosamine contamination

• D-0544-2026 and D-0545-2026: Zydus Pharmaceuticals (USA) Inc. is recalling Erythromycin Tablets USP at both the 250 mg and 500 mg strengths (30-count bottles, NDCs 70710-1047-3 and 70710-1048-3), manufactured by Zydus Lifesciences Ltd. in Ahmedabad. The 2026-04-29 firm-initiated recalls cite CGMP deviations and detection of N-Nitroso-Desmethyl-Erythromycin above the acceptable intake limit — a probable human carcinogen concern that continues the FDA's broader nitrosamine enforcement trajectory.

Sterility and particulate failures

• D-0546-2026: UCB Biosciences Inc. is recalling Cimzia (certolizumab pegol) 2x200 mg/mL prefilled syringes — including commercial (NDC 50474-710-79), professional sample, and starter kit configurations — for lack of assurance of sterility. Posted 2026-05-08, the action affects a high-cost biologic used in Crohn's disease and rheumatoid arthritis where injection-site infection risk is material.
• D-0548-2026: IntegraDose Compounding Services LLC (Shoreview, MN) is recalling Fentanyl Citrate Sterile CADD for Injection, 2,250 mcg/50 mL in sterile water (NDC 71139-6030-1), as subpotent. The 2026-05-12 firm-initiated recall raises acute risk of inadequate analgesia in CADD pump-dependent patients.
• D-0541-2026: Lupin Pharmaceuticals Inc. is recalling Liraglutide Injection 18 mg/3 mL (2-pen NDC 70748-346-02 and 3-pen NDC 70748-346-03), manufactured by Lupin Limited in Nagpur, India, after a white thread-like particulate was identified in the cartridge. The 2026-04-24 action adds to ongoing scrutiny of GLP-1 supply chains.

Labeling

• D-0538-2026: Safecor Health, LLC (Columbus, OH) is recalling Atomoxetine HCl 10 mg unit-dose capsules (NDC 64380-474-01) after a label mix-up in which 25 mg capsules were packaged as the 10 mg strength. The 2026-04-30 recall presents a 2.5x overdose risk for ADHD patients, particularly pediatric titrations.

Class III — Cross-Contamination in Primidone Supply

Three concurrent recalls trace to API cross-contaminated with trace Acemetacin at Lannett Company's manufacturing operations, propagating downstream to multiple repackagers and distributors:

• D-0534-2026 and D-0535-2026: Golden State Medical Supply Inc. is recalling Primidone Tablets USP 50 mg (50-count, NDC 51407-637-05) and 250 mg (100-count, NDC 51407-638-01), both manufactured by Lannett and marketed by GSMS (Camarillo, CA). Both actions posted 2026-04-27.
• D-0537-2026: Amerisource Health Services LLC initiated a parallel recall on 2026-05-01 of Primidone Tablets USP 50 mg in 100-tablet unit-dose carton (NDC 68084-202-01; individual dose NDC 68084-202-11), distributed by American Health Packaging (Columbus, OH).

Acemetacin is an NSAID not approved in the U.S.; while contamination is at trace levels (driving the Class III designation), the breadth across distributors warrants pharmacy-level lot reconciliation for epilepsy patients on chronic primidone therapy.