FDA Recall D-0256-2026
SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ
Class III Ongoing 135 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Recall record
- Recall number
D-0256-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the USA
- Recall initiated
- 2025-12-30
- Classified by FDA Center
- 2026-01-13
- FDA published
- 2026-01-21
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- FLUOCINOLONE ACETONIDE
- Generic name(s)
- FLUOCINOLONE ACETONIDE
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
51672-1365- Route(s)
- TOPICAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.