← FDA ENFORCEMENT
D-0475-2026Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Ongoing
Report date
2026-04-22
Distribution
Nationwide in the USA.
Firm state
NJ
Product quantity
24,672 15 g tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot# AD76252, Exp Date: 6/30/2026.

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.