Shiseido Future Solution LX Universal Defense SPF 50+ — Class II drug recall D-0215-2018
Terminated recall by SHISEIDO AMERICA INC., reported 2018-01-24, distributed nationwide. GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
| Recall number | D-0215-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHISEIDO AMERICA INC., East Windsor, NJ, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2021-06-24 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 58411-0256-60 |
Product
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
Reason for recall
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
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-0215-2018. 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.