Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
What was recalled
Fluocinonide, USP, 0.05% Cream, 15g 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 51672-1386-1
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 51672-1386-1
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0475-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fluocinonide recalls
See all
Class II · Moderate risk Ongoing
Fluocinonide
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Terminated
Fluocinonide Topical Solution USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Fluocinonide Gel USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Fluocinonide Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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