Lupin Pharmaceuticals Clobetasol propionate Cream Recall

Why it was recalled

Subpotent Drug: Low assay result observed during long-term stability testing.

Product description

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

Lot numbers, UPCs & expiration codes

Lot#: K101033; Exp 6/2024

Where it was sold

USA Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0174-2023
Classification: Class III
Status: Terminated
Recall initiated: Jan 20, 2023
FDA report date: Feb 1, 2023
Quantity: 5720 tubes
Recall type: Voluntary: Firm initiated
Recalling firm: Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0174-2023, exactly as published.

Show all FDA fields

City: Baltimore
State: MD
Status: Terminated
Country: United States
Event ID: 91532
Address: Harborplace Tower
Address (line 2): 111 S Calvert St Fl 21st
Code information: Lot#: K101033; Exp 6/2024
Postal code: 21202-6174
Report date: Feb 1, 2023
Product type: Drugs
Recall number: D-0174-2023
Classification: Class III
Recalling firm: Lupin Pharmaceuticals Inc.
Product quantity: 5720 tubes
Termination date: Jan 16, 2024
Reason for recall: Subpotent Drug: Low assay result observed during long-term stability testing.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: USA Nationwide
Recall initiation date: Jan 20, 2023
Initial firm notification: E-Mail
Center classification date: Jan 23, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0174-2023, published Feb 1, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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