Clobetasol Propionate Cream USP recall
FDA recall D-0789-2026 · initiated Aug 3, 2026
Lupin Pharmaceuticals Inc. recalled Clobetasol Propionate Cream USP in Aug 2026 — an FDA Class II recall (D-0789-2026) because Failed content uniformity specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed content uniformity specifications.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5082 tubes
Details
- 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.
- Recalling company
- Lupin Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Aug 3, 2026
- FDA report date
- Sep 2, 2026
Frequently asked
- Was Clobetasol Propionate Cream USP recalled?
- Lupin Pharmaceuticals Inc. recalled Clobetasol Propionate Cream USP in Aug 2026 — an FDA Class II recall (D-0789-2026) because Failed content uniformity specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clobetasol Propionate Cream USP recalled?
- Per the FDA enforcement record, the reason for recall D-0789-2026 was: Failed content uniformity specifications.
- Is a recalled Clobetasol Propionate Cream USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clobetasol Propionate Cream USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0789-2026.