N-Acetyl-L-Cysteine for Injection recall — Class II (D-0064-2026) · pharmaranks
Class IIOngoing
N-Acetyl-L-Cysteine for Injection recall
FDA recall D-0064-2026 · initiated Jul 30, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Details
Product
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Recalling company
GenoGenix LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
US Nationwide.
Initiated
Jul 30, 2025
FDA report date
Oct 15, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.