Clobetasol Propionate Solution (Oxalis Labs) – container defect (2019)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
Brand
Oxalis Labs
Lot Codes / Batch Numbers
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019, PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Products Sold
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Oxalis Labs is recalling Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Phar due to Defective Container; complaints of leakage.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Container; complaints of leakage.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026