CLASS III Drug recall · Reported 1 Feb 2023 · 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 20 Jan 2023 and the FDA has classified it as Class III.
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-0174-2023
- FDA event ID
- 91532
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jan 2023
- FDA classified
- 23 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Jan 2023 | Recall initiated by company | |
| 23 Jan 2023 | Classified by FDA | +3 days |
| 1 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Low assay result observed during long-term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Low assay result observed during long-term stability testing.
Which lots are affected?
Lot#: K101033; Exp 6/2024
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
Other Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| 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 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 |