Clobetasol propionate is a very potent topical corticosteroid prescribed to treat a variety of skin conditions, including eczema, psoriasis, and dermatitis. It works by reducing inflammation, swelling, redness, and itching. Given its strength and common usage, questions about its safety and potential recalls are valid. As of late 2025, there are no new, major recalls affecting clobetasol propionate cream. However, it's important to understand past events to remain a vigilant consumer.
Recent and Past Clobetasol Propionate Recalls
While searches for 2024 and 2025 do not show new recalls, there have been significant recalls in the recent past that consumers should be aware of.
Taro Pharmaceuticals 2021 Recall
In December 2021, Taro Pharmaceuticals U.S.A., Inc. issued a voluntary recall for one lot of its Clobetasol Propionate Ointment USP, 0.05% (Lot AC13786, Exp. Dec 2022). The recall was initiated after routine testing discovered the presence of Ralstonia pickettii bacteria.
This bacterium is commonly found in soil and water and is unlikely to cause infections in healthy individuals with intact skin. However, for individuals who are immunocompromised or have broken skin (due to conditions like psoriasis or abrasions), exposure could potentially lead to serious, life-threatening systemic infections. The corticosteroid component can enhance absorption, increasing this risk. At the time of the recall, Taro had not received any reports of adverse events related to the contaminated lot. The FDA has since marked this recall as completed and terminated.
Lupin Pharmaceuticals 2023 Recall
In February 2023, Lupin, another pharmaceutical company, recalled 5,720 tubes of clobetasol propionate cream from the U.S. market. The recall was initiated after the FDA found the product to be of poor quality. Specifically, the reason cited was "subpotent drug: Low assay result observed during long-term stability testing". This indicates the medication was not as strong or effective as it was supposed to be. This was a Class III recall, which the FDA uses for situations where use of or exposure to a violative product is not likely to cause adverse health consequences.
What is Clobetasol Propionate and How is It Used?
Clobetasol propionate is a super-high potency corticosteroid used for short-term treatment of inflammatory skin conditions. It is available in various forms, including cream, ointment, gel, foam, and shampoo.
Common Uses:
- Plaque Psoriasis: An autoimmune condition causing itchy, scaly patches.
- Eczema: A condition that makes skin red and itchy.
- Contact Dermatitis: A skin rash caused by direct contact with a substance.
- Seborrheic Dermatitis: A condition causing scaly patches and red skin, mainly on the scalp.
Due to its potency, treatment is typically limited in duration unless otherwise directed by a doctor. It should not be used on the face, groin, or underarms unless specifically instructed by a healthcare provider.
Potential Side Effects
Like all medications, clobetasol propionate can cause side effects. Common, milder side effects can include burning, stinging, itching, or dryness at the application site. More serious, though less common, side effects can occur, especially with prolonged use or application over large areas of skin. These include:
- Skin thinning, stretch marks, or discoloration.
- Acne or small red bumps (folliculitis).
- Cushing's syndrome (caused by excessive cortisol levels).
- Adrenal insufficiency.
- Vision problems like glaucoma or cataracts.
- Slowed growth in children.
Clobetasol vs. Other Topical Steroids
Topical corticosteroids are classified by their potency. Understanding where clobetasol fits can help in discussions with your doctor.
| Feature | Clobetasol Propionate 0.05% | Hydrocortisone 1% (OTC) | Triamcinolone Acetonide 0.1% |
|---|---|---|---|
| Potency | Super-high (Class I) | Low (Class VII) | Medium (Class IV) |
| Primary Use | Severe, resistant dermatoses, short-term use | Mild irritation, itching, rashes | Mild to moderate dermatoses |
| Duration | Typically limited duration | Can be used for longer periods | As directed by a physician |
| Risks | Higher risk of systemic side effects, skin atrophy | Lower risk of side effects | Moderate risk, lower than clobetasol |
How to Check for Drug Recalls
Patients can stay informed about medication safety through several official channels:
- FDA's Website: The U.S. Food and Drug Administration maintains a searchable database of drug recalls, market withdrawals, and safety alerts.
- MedWatch Program: The FDA's MedWatch program allows consumers and healthcare professionals to report adverse events and receive safety information.
- Pharmacy Notifications: Your pharmacy may notify you directly if a medication you have received is part of a recall.
If you find your medication has been recalled, do not stop using it abruptly. Contact your doctor or pharmacist first to discuss alternative treatments.
Conclusion
While there are no active, widespread recalls for clobetasol propionate cream as of September 2025, past recalls by manufacturers like Taro and Lupin highlight the importance of regulatory oversight and quality control. These events, caused by bacterial contamination and sub-potency, underscore the potential risks, especially for vulnerable populations. Patients should use this potent medication exactly as prescribed, be aware of potential side effects, and know how to check for official recall information to ensure their safety. You can find more information about recalls on the FDA's website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
