RecallRadar

FDA Drug recall D-0789-2026

Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,…

On 2026-09-02 the FDA classified a Class II recall of Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,… by Lupin Pharmaceuticals, citing failed content uniformity specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0789-2026
ClassificationClass II
Statusongoing
Initiated2026-08-03
Published2026-09-02
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

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.

Reason

Failed content uniformity specifications.

Identifiers

ndc68180-956-01
ndc68180-956-02
ndc68180-956-03
ndc68180-956-04
code_infoLot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.