FDA recall, , Moderate risk
Taro Fluocinonide Cream
Fluocinonide cream failed viscosity specifications.
Summary by Recall Canary from the FDA notice
What happened
SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, New Jersey, began a recall on March 25, 2026, of Fluocinonide, USP, 0.05% Cream because the product failed viscosity specifications. Out of Specification results, above the specification limit, in viscosity were noted during stability testing.
The recall was added to the FDA's Enforcement Report and classified on April 13, 2026, with nationwide distribution in the USA. The affected products are 30g, 15g, and 60g tubes, manufactured by Taro Pharmaceuticals Inc. and distributed by Taro Pharmaceuticals U.S.A., Inc.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your tube affected?
3 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only
- NDC
- 51672-1386-2
- Lot code
- AD76251
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only
- NDC
- 51672-1386-1
- Lot code
- AD76252
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only
- NDC
- 51672-1386-3
- Lot code
- AD76250
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98677
- Recall numbers
- D-0475-2026 to D-0477-2026
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
