The Recall Desk
ModerateFDA (Drugs)·D-0216-2018·Announced 2018-01-24

Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations

Shiseido America Inc. is recalling the Future Solution LX Discovery Set because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to GMP deviations in API manufacturing. As no specific illnesses, injuries, or high-risk pathogens are reported in the source text, and the hazard is related to quality control rather than a direct acute threat like a known pathogen or structural defect, it falls under the Moderate category for minor labeling/quality errors or precautionary recalls.

Plain-English summary

Shiseido America Inc. is recalling the Shiseido Future Solution LX Discovery Set. The product contains SPF 50+ ingredients including octinoxate, octocrylene, oxybenzone, and zinc oxide, and is packaged in 15 mL tubes. The recall is due to Good Manufacturing Practice (GMP) deviations, specifically that the manufacturing of active pharmaceutical ingredient (API) material did not meet GMP and quality requirements.

The product was distributed nationwide. The specific SKU number for the recalled item is 95167. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
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,
Manufacturer
SHISEIDO AMERICA INC.
Category
Drug — Cosmetic / Sunscreen
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • SKU#: 95167

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by SHISEIDO AMERICA INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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