CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Shiseido Future Solution LX Discovery Set contains SPF 50+ recalled
Shiseido America is recalling Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 9%, octocrylebe 0%, distributed nationwide in the US. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0216-2018
- FDA event ID
- 78791
- Recalling firm
- Shiseido America, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2017
- FDA classified
- 12 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Sunscreen & Personal Care
Timeline
| 14 Dec 2017 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +29 days |
| 24 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Shiseido Future Solution LX Discovery Set 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,
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Is Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 9%, octocrylebe 0% recalled?
Yes. Shiseido America recalled Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 9%, octocrylebe 0% on 14 Dec 2017. The recall is Class II and its status is Terminated. Recall number D-0216-2018.
Why was it recalled?
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Which lots are affected?
SKU#: 95167
Where was it sold?
Product was distributed nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shiseido America
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Shiseido Future Solutions LX Triple Points Bonus contains recalled | Shiseido America | Packaging Defects | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Luxurious Eye & Lip Collection recalled | Shiseido America | Packaging Defects | Nationwide |
| Drug | CLASS II | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion recalled | Shiseido America | Processing Deviation | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Universal Defense SPF 50+ recalled | Shiseido America | Packaging Defects | Nationwide |
Other Shiseido future recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Shiseido Future Solutions LX Triple Points Bonus contains recalled | Shiseido America | Packaging Defects | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Luxurious Eye & Lip Collection recalled | Shiseido America | Packaging Defects | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Universal Defense SPF 50+ recalled | Shiseido America | Packaging Defects | Nationwide |