Sun Pharmaceutical Fluocinonide Cream Recall: Failed Viscosity Testing
Sun Pharmaceutical Industries recalls 0.05% Fluocinonide cream due to failed viscosity tests. This may affect stability and product performance. Contact for details.
Recall notice
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries is recalling 0.05% Fluocinonide cream tubes that failed viscosity testing during stability checks. This could lead to product instability, though serious injury risks are not specified in the recall. Read more at govinfonow.com/recall/31387-sun-pharmaceutical-fluocinonide-cream-recall-failed-viscosity-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/31387-sun-pharmaceutical-fluocinonide-cream-recall-failed-viscosity-testing · Updated August 17, 2026 · FDA enforcement record: FDA #D-0476-2026
Cite this page
“Sun Pharmaceutical Fluocinonide Cream Recall: Failed Viscosity Testing.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31387-sun-pharmaceutical-fluocinonide-cream-recall-failed-viscosity-testing. Based on FDA recall #D-0476-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0476-2026%22&limit=1).
Why it’s dangerous
The cream failed viscosity tests during stability testing, meaning it may not maintain proper consistency over time. This could affect product performance but does not indicate immediate safety risks.
Who’s affected
Prescription users of the 0.05% Fluocinonide cream in 30g tubes. Those with the specific lot number AD76251 are most at risk.
How to tell if you have this one
Check for the product name 'Fluocinonide, USP, 0.05% Cream, 30g tube' with lot number AD76251. It was manufactured in Canada and distributed by Taro Pharmaceuticals U.S.A.
- Brand
Sun Pharmaceutical Industries- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide in the USA.- NDC
51672-1386-1, 51672-1386-2, 51672-1386-3, 51672-1386-4
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0475-2026 | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1; Lot# AD76252, Exp Date: 6/30/2026. | 24,672 15 g tubes |
| D-0476-2026 | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.; Lot# AD76251, Exp Date: 6/30/2026. | 41,712 30g tubes |
| D-0477-2026 | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.; Lot# AD76250, Exp Date: 6/30/2026. | 2,640 60g tubes |
What to do — step by step
Check Product Details
Look for the lot number AD76251 on the tube label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Sun Pharmaceutical Industries recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0476-2026 (March 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0476-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.