Fluocinolone Acetonide Solution Topical Solution USP recall: Impurity Out of Spec
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC…
Why was Fluocinolone Acetonide Solution Topical Solution USP recalled?
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- Product
- Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC…
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 24,624 bottles
- Distribution
- Nationwide within the USA
- Recall date
- January 21, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)