Quick Facts at a Glance
- Recall Date
- December 30, 2025
- Hazard Level
- HIGH
- Brands
- Fluocinolone Acetonide, Sun Pharmaceutical Industries, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fluocinolone Acetonide, Sun Pharmaceutical Industries, Inc.
- Product type
- Topical Solution
- Model numbers
- AD81290, AD81291, AD81292, AD81293
- UPC codes
- 51672-1365, 51672-1365-2, 51672-1365-4
- Sizes
- 60 mL
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 30, 2025
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Fluocinolone Acetonide Topical Solution is a prescription corticosteroid used to treat inflammatory skin conditions. It is labeled Rx-only with NDC 51672-1365-4 and distributed nationwide in 60-mL bottles.
Why This Is Dangerous
An out-of-specification impurity D was detected in the affected lots. The notice does not quantify potential health effects.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must stop using the product. The recall is active nationwide.
Practical Guidance
How to identify if yours is affected
- Check the label for NDC 51672-1365-4.
- Check the bottle for Lot numbers AD81290, AD81291, AD81292, or AD81293.
- Check Exp. Date 1/31/2027.
Where to find product info
Label on bottle includes NDC and lot numbers; expiration date is on the packaging.
What timeline to expect
Remedy details beyond stopping use are not specified. Expect further instructions by recall letter from the manufacturer.
If the manufacturer is unresponsive
- Consult FDA recall resources
- Ask your healthcare provider for guidance
How to prevent similar issues
- Verify NDC numbers when obtaining prescription products
- Watch for recall notices from manufacturers
- Consult your physician before using any recalled medication as a substitute
Documentation advice
Keep the recall notice, packaging, and all communications; document any adverse events and correspondence
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Product Details
Product: Fluocinolone Acetonide Topical Solution USP 0.01% in 60-mL bottles. NDC 51672-1365-4. Rx-only. Distributed by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. 24,624 bottles recalled. Sold nationwide in the USA. Lot numbers: AD81290, AD81291, AD81292, AD81293. Exp. Date: 1/31/2027.
Key Facts
- 24,624 bottles recalled nationwide
- Hazard: out-of-specification impurity D
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Safety Guide
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