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.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Sun Pharmaceutical is recalling 60-mL bottles of Fluocinolone Acetonide Solution Topical Solution (0.01%) because they contain an impurity that could be unsafe. This recall affects patients using prescription steroid creams who have been prescribed this medication.
The product contains an impurity (D) that failed quality specifications. This could potentially lead to safety issues for patients using the medication, though the exact risk is not clearly described in the recall notice.
Patients with a prescription for this topical steroid cream are affected. Those using the product without a prescription are not impacted since it's Rx-only.
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.
Look for the NDC code 51672-1365-4 and lots AD81290-AD81293 on the bottle.
The recall states the product contains an impurity that failed quality specifications, but the exact safety risk is not clearly described.
Check for 60-mL bottles with NDC 51672-1365-4 and lots AD81290-AD81293.
The recall does not specify a remedy, so there is no instruction to stop using it.
We’ve drafted a message you can send Sun Pharmaceutical Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0256-2026 — Sun Pharmaceutical Industries Sun Pharmaceutical Industries Hello, I own a Sun Pharmaceutical Industries that is covered by recall D-0256-2026 from Sun Pharmaceutical Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
