Fluocinonide recall
FDA recall D-0477-2026 · initiated Mar 25, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Fluocinonide in Mar 2026 — an FDA Class II recall (D-0477-2026) because Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 2,640 60g tubes
Details
- Product
- Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Mar 25, 2026
- FDA report date
- Apr 22, 2026
Frequently asked
- Was Fluocinonide recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Fluocinonide in Mar 2026 — an FDA Class II recall (D-0477-2026) because Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fluocinonide recalled?
- Per the FDA enforcement record, the reason for recall D-0477-2026 was: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Is a recalled Fluocinonide 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 Fluocinonide are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot# AD76250, Exp Date: 6/30/2026.. 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-0477-2026.