Recalls / Class III
Class IIID-0256-2026
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
- Brand name
- Fluocinolone Acetonide
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Topical
- NDC
- 51672-1365
- FDA application
- ANDA089124
- Affected lot / code info
- Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 24,624 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2025-12-30
- FDA classified
- 2026-01-13
- Posted by FDA
- 2026-01-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0256-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.