CLASS II ONGOING Drug recall · Reported 2 Sep 2026 · FDA Enforcement Report
Clobetasol Propionate Cream USP, 0.05% tube recalled
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream USP, 0.05% tube, distributed nationwide in the US. The recall was initiated on 3 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0789-2026
- FDA event ID
- 99544
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 3 Aug 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +23 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed content uniformity specifications.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed content uniformity specifications.
Which lots are affected?
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Cream recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled | Preferred Pharmaceuticals | Potency & Assay | IL |
| Drug | CLASS II | Clobetasol Propionate Lotion recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |