Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmace… recall
FDA recall D-0209-2026 · initiated Oct 31, 2025
Blossom Pharmaceuticals recalled Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… in Oct 2025 — an FDA Class II recall (D-0209-2026) because cGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7920 bottles
Details
- Product
- Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
- Recalling company
- Blossom Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Oct 31, 2025
- FDA report date
- Dec 10, 2025
Frequently asked
- Was Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… recalled?
- Blossom Pharmaceuticals recalled Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… in Oct 2025 — an FDA Class II recall (D-0209-2026) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… recalled?
- Per the FDA enforcement record, the reason for recall D-0209-2026 was: cGMP deviations
- Is a recalled Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage… are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: A352505. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0209-2026.