RecallRadar

FDA Drug recall D-0218-2018

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%)…

On 2018-01-24 the FDA classified a Class II recall of Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%)… by Shiseido America, citing GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0218-2018
ClassificationClass II
Statusterminated
Initiated2017-12-14
Published2018-01-24
Last updated2026-09-13 11:52 UTC
CompanyShiseido America
DistributionUS

Product

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 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_infoSKU#: 95284

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-0218-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.