The FDA Desk — 2026-06-06

TITLE: FDA Desk — Class I recall of MG217 cream for Staph aureus; nitrosamine impurity hits Zydus erythromycin

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Top Alert: Class I Recall

• D-0553-2026 — Wisconsin Pharmacal Company is recalling MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%, 6 oz), manufactured by Pharmacal in Jackson, WI, after confirmed microbial contamination with *Staphylococcus aureus* in this non-sterile OTC topical — a reasonable probability of serious adverse health consequences for users with broken skin. Initiated 2026-04-24.

Class II — Sterility, Subpotency, and Particulate Concerns

• D-0546-2026 — UCB Biosciences is recalling Cimzia (certolizumab pegol) 2x200 mg/mL prefilled syringes, including commercial, professional sample, and starter kit configurations (NDCs 50474-710-79/-80/-81), for lack of assurance of sterility in an injectable biologic — a notable risk given the immunosuppressed Cimzia patient population. Initiated 2026-05-08.
• D-0548-2026 — IntegraDose Compounding Services (Shoreview, MN) is recalling compounded fentanyl citrate sterile CADD for injection, 2,250 mcg/50 mL (NDC 71139-6030-1) as subpotent, raising under-dosing and breakthrough-pain risk in pump-administered patients. Initiated 2026-05-12.
• D-0541-2026 — Lupin Pharmaceuticals is recalling liraglutide injection 18 mg/3 mL pens (2-pack NDC 70748-346-02; 3-pack -03), manufactured by Lupin Limited in Nagpur, India, after a white thread-like particulate was identified in cartridges of the GLP-1 product. Initiated 2026-04-24.

Class II — Nitrosamine Impurity in Zydus Erythromycin

Zydus Pharmaceuticals (USA) initiated parallel recalls on 2026-04-29 of erythromycin tablets manufactured by Zydus Lifesciences Ltd. (Ahmedabad, India), citing CGMP deviations and N-Nitroso-Desmethyl-Erythromycin levels above the acceptable intake limit — continuing the broader nitrosamine-impurity pattern that has driven multiple recent recalls across generic drug supply.

• D-0545-2026 covers erythromycin 500 mg tablets, 30-count bottles (NDC 70710-1048-3).
• D-0544-2026 covers erythromycin 250 mg tablets, 30-count bottles (NDC 70710-1047-3).

Class II — Labeling Mix-Up

• D-0538-2026 — Safecor Health (Columbus, OH) is recalling repackaged atomoxetine HCl 10 mg unit-dose capsules (NDC 64380-474-01) after a label mix-up in which 25 mg capsules were labeled as 10 mg — a 2.5× overdose risk for ADHD patients, particularly pediatric ones. Initiated 2026-04-30.

Class III — Primidone Cross-Contamination With Acemetacin API

Three coordinated Class III recalls flag cross-contamination of primidone tablets with trace acemetacin API (an NSAID not approved in the U.S.), traced to Lannett Company manufacturing. The Class III designation reflects low likelihood of adverse health consequences, but prescribers of this antiepileptic should note the lot exposure.

• D-0537-2026 — Amerisource Health Services / American Health Packaging primidone 50 mg, 100-tablet unit-dose blister carton (NDC 68084-202-01). Initiated 2026-05-01.
• D-0534-2026 — Golden State Medical Supply primidone 50 mg, 50-count bottles (NDC 51407-637-05). Initiated 2026-04-27.
• D-0535-2026 — Golden State Medical Supply primidone 250 mg, 100-count bottles (NDC 51407-638-01). Initiated 2026-04-27.