UnratedDrug recall · FDA · Published December 30, 2025
Sun Pharmaceutical Fluocinolone Acetonide Solution Recall: Impurity Risk
Sun Pharmaceutical recalls 0.01% Fluocinolone Acetonide Solution Topical Solution bottles due to impurity D. This may affect safety for patients using prescription steroid creams.
“Sun Pharmaceutical Fluocinolone Acetonide Solution Recall: Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31570-sun-pharmaceutical-fluocinolone-acetonide-solution-recall-impurity-risk. Based on FDA recall #D-0256-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0256-2026%22&limit=1).
The FDA announced on Dec. 30, 2025, that Sun Pharmaceutical Industries Inc. is recalling Fluocinolone Acetonide Solution Topical Solution USP due to failed impurity specifications. The recall affects 24,624 bottles distributed nationwide.
The recall is due to an out-of-specification result for the known impurity D. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (Sept. 14, 2026), Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026), and Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026). Other recent recalls of similar products include Somerset Therapeutics Dexamethasone Injection Recall (Feb. 4, 2026), Lupin Ganirelix Acetate Injection Recall (Nov. 13, 2025), and SUN PHARMA Ciclopirox Shampoo 1% Recall (Dec. 9, 2025).
How to tell if you have this one
Check for 60-mL bottles labeled 'Fluocinolone Acetonide Solution Topical Solution USP 0.01%'. The product was distributed by Taro Pharmaceuticals with NDC 51672-1365-4 and lots AD81290-AD81293.
Brand
Sun Pharmaceutical Industries
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 51672-1365-4 and lots AD81290-AD81293 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0256-2026 (December 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0256-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.