Life sciences · Safety recall

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

U.S. Food and Drug Administration · September 2, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA has initiated a nationwide Class II recall of clobetasol propionate cream 0.05% (60 g tubes, NDC 68180-956-04) manufactured by Lupin Limited for India-based Lupin Pharmaceuticals due to failed content uniformity specifications. This is a safety and quality action; clinical efficacy or comparative benefit data are not part of this enforcement record.

What was studied

Safety recall. Patients in the USA who received or may receive this specific product.. Manufactured in Pithampur (MP), India; distributed USA nationwide..

Key findings

Product: Clobetasol Propionate Cream USP, 0.05%, 60 g tube Classification: Class II recall Status: Ongoing

Safety

No clinical trial data, efficacy data, or adverse event data are provided in this regulatory action.

Who this may help

Healthcare providers and patients should be aware that distributed lots of this product may not contain uniform active ingredient concentration, potentially affecting therapeutic efficacy or safety. Clinicians should verify product lot numbers against the recall and consider alternative sources.

Plain-language summary

FDA Class II recall for failed content uniformity in clobetasol propionate cream; affects drug safety and product integrity nationwide.

Study design

As stated by the source record.

SettingManufactured in Pithampur (MP), India; distributed USA nationwide.

Reported figures

Quoted from the source exactly as published.

NDC68180-956-04

Strength0.05%

Package size60 g tube

Clinical bottom line

Caveats

Record does not specify which lots are affected or the scope of distribution beyond 'USA Nationwide'.
No clinical trial data, efficacy data, or adverse event data are provided in this regulatory action.
Content uniformity failure mechanism and degree of deviation from specifications are not detailed.
No information on whether product was distributed, amount in market, or patient exposure.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action; no study design applicable.

Directness

insufficient

Direct regulatory action identifying specific product and defect.

Consistency

insufficient

Single recall action; no comparative consistency data.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No sample size or testing methodology reported.

Source abstract

FDA enforcement report D-0789-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Lupin Pharmaceuticals Inc.. Initiated as: Voluntary: Firm initiated. 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 for recall: Failed content uniformity specifications. Distribution: USA Nationwide

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Lupin Pharmaceuticals