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Moderate riskFDA DrugClass III

Sun Pharmaceutical fluocinolone solution recalled for impurity level

Taro Pharmaceuticals is recalling specific lots of fluocinolone acetonide topical solution (0.01%) because testing found higher-than-allowed levels of an impurity. The affected lots were distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. Check your fluocinolone acetonide bottle for lot number AD81290, AD81291, AD81292, or AD81293 with expiration date 1/31/2027.
  2. Stop using the medication if your bottle matches these lot numbers.
  3. Contact your pharmacy or doctor for a replacement or alternative treatment.
  4. Do not flush the medication down the toilet; ask your pharmacy how to dispose of it safely.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
24,624 bottles
Illnesses reported
None reported
Manufactured in
2 Independence Way, Princeton, NJ, United States
Classification
Class III
Recall number
D-0256-2026

In the FDA's words

Description
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 Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027 Distribution: Nationwide within the USA Affected quantity: 24,624 bottles
Hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

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