Elevated site urgencyFDA Class II

Fluocinonide, USP, 0

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Agency
FDA Drug
Recall date
Mar 25, 2026
Status
Ongoing
Company
SUN PHARMACEUTICAL INDUSTRIES INC

1. What product was recalled?

Fluocinonide, USP, 0

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.

Quantity: 41,712 30g tubes

Code or lot text: Lot# AD76251, Exp Date: 6/30/2026.

LOT
Exp Date: 6/30/2026.
LOT
Lot# AD76251
NDC
51672-1386
NDC
51672-1386-1
NDC
51672-1386-2
NDC
51672-1386-3
NDC
51672-1386-4
RECALL-NUMBER
D-0476-2026

Fluocinonide, USP, 0

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.

Quantity: 2,640 60g tubes

Code or lot text: Lot# AD76250, Exp Date: 6/30/2026.

LOT
Exp Date: 6/30/2026.
LOT
Lot# AD76250
NDC
51672-1386
NDC
51672-1386-1
NDC
51672-1386-2
NDC
51672-1386-3
NDC
51672-1386-4
RECALL-NUMBER
D-0477-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.