Lupin Pharmaceuticals recall: Clobetasol Propionate Cream USP
Lupin Pharmaceuticals Inc. is recalling Clobetasol Propionate Cream USP – 5082 tubes. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Clobetasol Propionate Cream USP |
| Brand | Lupin Pharmaceuticals |
| Company | Lupin Pharmaceuticals Inc. |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 3, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 5082 tubes |
| Recall ID | 99544 |
Recalled products
- 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.
- FDA recall number
- D-0789-2026
- Codes, lots and dates
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Quantity
- 5082 tubes
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99544
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Naples, FL, United States
Why it was recalled
The reason the FDA lists: “Failed content uniformity specifications.”
Where it was sold
Nationwide. Distribution as the FDA records it: “USA Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99544, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Lupin Pharmaceuticals Clobetasol Propionate Cream USP recalled?
Yes. Lupin Pharmaceuticals Inc. recalled it on August 3, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed content uniformity specifications.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.