Clobetasol Propionate Cream Recalled Due to Failed Content Uniformity Specifications
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for clobetasol propionate cream, USP, 0.05%, 60 g. The affected batches have been identified as Lots KA00308 (expires October 2026) and KB00427 (expires April 2028), containing 5082 tubes.
- The recall was initiated by Lupin Pharmaceuticals, Inc due to failed content uniformity specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Clobetasol is used to treat symptoms of eczema and psoriasis.
The FDA has issued a Class II recall for clobetasol propionate cream, USP, 0.05%, 60 g, affecting 5082 tubes. This product is manufactured by Lupin Limited in India and is being recalled by Lupin Pharmaceuticals, Inc based in Naples, Florida. The recall was initiated on August 3, 2026, and received a Class II classification on August 26, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated due to the product’s failure to meet content uniformity specifications. This deficiency affects Lots KA00308 and KB00427, which will expire in October 2026 and April 2028, respectively. Lupin Pharmaceuticals sent out public notices via email, fax, letter, telephone, and personal visit; no press release has been issued for this recall.
Clobetasol is a corticosteroid used to relieve redness, itchiness, and swelling caused by eczema and psoriasis. Pharmacists should identify and quarantine Lots KA00308 and KB00427, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. September 2, 2026. Accessed September 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221805
