SUN PHARMACEUTICAL INDUSTRIES INC 2026-01-21 Health moderate FDA
Health · FDA · Recall #FDA-D-0256-2026
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only,… Recall
Issued January 21, 2026 · SUN PHARMACEUTICAL INDUSTRIES INC
In January 2026, SUN PHARMACEUTICAL INDUSTRIES INC recalled the Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only,…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What you should do
- 1 Stop using Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SUN PHARMACEUTICAL INDUSTRIES INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Health
- Recall date
- January 21, 2026
- Units affected
- Not reported
- Sold at
- Nationwide within the USA
- Recall number
- FDA-D-0256-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- SUN PHARMACEUTICAL INDUSTRIES INC has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.