Fluocinolone Acetonide Solution Topical Solution USP recall
FDA recall D-0256-2026 · initiated Dec 30, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Fluocinolone Acetonide Solution Topical Solution USP in Dec 2025 — an FDA Class III recall (D-0256-2026) because Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 24,624 bottles
Details
- Product
- Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
- Recalling company
- Sun Pharm Industries
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Dec 30, 2025
- FDA report date
- Jan 21, 2026
Frequently asked
- Was Fluocinolone Acetonide Solution Topical Solution USP recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Fluocinolone Acetonide Solution Topical Solution USP in Dec 2025 — an FDA Class III recall (D-0256-2026) because Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fluocinolone Acetonide Solution Topical Solution USP recalled?
- Per the FDA enforcement record, the reason for recall D-0256-2026 was: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Is a recalled Fluocinolone Acetonide Solution Topical Solution USP 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 Fluocinolone Acetonide Solution Topical Solution USP are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027. 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-0256-2026.