Fluocinolone Acetonide Solution Topical Solution 0. Recall
Fluocinolone Acetonide Solution Topical Solutio... has been recalled due to failed impurities/degradation specifications: out of specification result was obtained for the known impurity d.. Both healthcare providers and consumers may be affected by this recall. Check the official FDA notice for specific lot numbers and return or disposal instructions.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 4, 2026.
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Check if you qualifyKey facts
- Date announced
- December 30, 2025
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
Fluocinolone Acetonide Solution Topical Solutio... has been recalled due to failed impurities/degradation specifications: out of specification result was obtained for the known impurity d.. Both healthcare providers and consumers may be affected by this recall. Check the official FDA notice for specific lot numbers and return or disposal instructions.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Fda
- Category
- drug
- Source agency
- FDA
- Announced
- December 30, 2025
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
| # | Model |
|---|---|
| 1 | Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1## Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY
- 2NDC 51672-1365-4 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. What to do:
- 3Stop using the product if your lot/model matches.
- 4Check the FDA notice for specifics.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- December 30, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027.
What is the remedy for this recall?
## 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 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: FDA recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
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Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- December 30, 2025
- Source agency
- FDA
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