August 2026 FDA Recall Clobetasol Propionate by Lupin Pharmaceuticals Inc.
D-0789-2026 - Failed content uniformity specifications.

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on August 3, 2026 for the product Clobetasol Propionate. The FDA reported the reason for recall as failed content uniformity specifications.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0789-2026

Reason for Recall
Failed content uniformity specifications.
Initiated
08-03-2026
Reported
09-02-2026
Quantity
5082 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99544
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.

Batch or Lot Expiration Information

Lot# : KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026

Affected Packages Involved in this Recall

68180-956-01 Clobetasol Propionate
68180-956-02 Clobetasol Propionate
68180-956-03 Clobetasol Propionate
68180-956-04 Clobetasol Propionate