Clobetasol Propionate Topical Solution USP — Class III drug recall D-0492-2019
Terminated recall by Oxalis Labs, reported 2019-02-20, distributed nationwide. Defective Container; complaints of leakage.
| Recall number | D-0492-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oxalis Labs, Theda, N/A, India |
| Recall initiated | 2019-01-11 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2019-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 53,358 bottles |
| Reason classes | packaging |
| NDC | 33342-0321, 33342-0321-39, 33342-0321-86 |
| Lot numbers | PCA801A, PCA802A, PCA803A, PCA804A, PCA805A, PCA806A, PCA807A |
| Expiration dates | 2019-12, 2020-04 |
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
Reason for recall
Defective Container; complaints of leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0492-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.