G & W Clobetasol Propionate Ointment 0 — Class III drug recall D-0945-2017
Terminated recall by G & W Laboratories, Inc., reported 2017-07-12, distributed nationwide. Failed impurities/degradation specifications: This product is being recalled due to out of specification resul
| Recall number | D-0945-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & W Laboratories, Inc., South Plainfield, NJ, United States |
| Recall initiated | 2017-06-02 |
| Classified | 2017-07-06 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 145,284 tubes |
| Reason classes | specification failure |
| NDC | 00713-0656, 00713-0656-15, 00713-0656-31, 00713-0656-37, 00713-0656-60 |
Product
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Reason for recall
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
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-0945-2017. 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.