FDA Drug recall D-0215-2018
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged i…
- FDA Drug
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged i… by Shiseido America, citing GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0215-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-14 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shiseido America |
| Distribution | US |
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
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Identifiers
| code_info | SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0215-2018%22
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