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Unrated Drug recall · FDA · Published December 14, 2017

Shiseido Future Solution LX SPF 50+ Recall: Manufacturing Quality Issues

Shiseido recalls Future Solution LX Universal Defense SPF 50+ due to manufacturing quality deviations. This may affect product safety. Check NDC 58411-256-60 or SKU numbers for affected items.

🇺🇸 FDA recall #D-0215-2018DrugShiseido ›
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Recalling firmSHISEIDO AMERICA INC.366 Princeton Hightstown Rd · East Windsor, NJ 08520-1411
✎ GovInfoNow plain-language explainer

What happened, in plain English

Shiseido is recalling its Future Solution LX Universal Defense SPF 50+ sunscreen because manufacturing quality issues could affect product safety. This recall affects specific sizes and packaging from certain distributors. Consumers should check the NDC or SKU numbers to see if their product is affected. Read more at govinfonow.com/recall/41015-shiseido-future-solution-lx-spf-50-recall-manufacturing-quality-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/41015-shiseido-future-solution-lx-spf-50-recall-manufacturing-quality-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0215-2018

Cite this page

“Shiseido Future Solution LX SPF 50+ Recall: Manufacturing Quality Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41015-shiseido-future-solution-lx-spf-50-recall-manufacturing-quality-issues. Based on FDA recall #D-0215-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0215-2018%22&limit=1).

Why it’s dangerous

The product was manufactured without meeting Good Manufacturing Practice (GMP) quality requirements. This means the sunscreen may not be safe for use as intended, potentially causing harm to users. However, the specific risk to consumers is not clearly described in the recall notice.

Who’s affected

Shiseido Future Solution LX Universal Defense SPF 50+ sunscreen users who purchased the product with NDC 58411-256-60 or specific SKU numbers from Shiseido Americas Corporation in New York. People using this sunscreen for sun protection are most at risk if the product was not properly manufactured.

How to tell if you have this one

Check the product label for NDC 58411-256-60 or SKU numbers: 8C52541 (2mL), 8B41841 (15mL), or 1155840-1155851, 0710341-0710342 (50mL). The product was distributed by Shiseido Americas Corporation in New York, NY.

  • Brand
    Shiseido
  • Category
    Drug
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Product was distributed nationwide.
Recall numberProduct, codes & lotsQuantity
D-0214-2018bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01; SKU#: BE8047201248,661 bottle and /tubes
D-0215-2018Shiseido 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; SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342N/A
D-0216-2018Shiseido 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,; SKU#: 95167N/A
D-0217-2018Shiseido Future Solution LX Luxurious Eye & Lip Collection 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; SKU#: 95393N/A
D-0218-2018Shiseido 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; SKU#: 95284N/A
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC 58411-256-60 or specific SKU numbers on the product label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.5 years after the firm started it.

1. Firm started the recall: Dec 14, 201712. FDA classified it Class II: Jan 12, 201823. Published in FDA’s Enforcement Report: Jan 24, 201834. FDA terminated the recall: Jun 24, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0215-2018 (December 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0215-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA