fluocinolone acetonidedrugHigh PriorityActive

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

fluocinolone acetonide 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 recalled by FDA. Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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.

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

What You Should Do

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.

Open Official Recall Notice Get Alerts for fluocinolone acetonide Devices

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.

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.

Frequently Asked Questions

Is my fluocinolone acetonide device affected?

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: fluocinolone acetonide recall hub and Food & Drug recall hub.