The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0218-2018·Announced 2018-01-24

Shiseido Future Solutions LX Triple Points Bonus Recalled for GMP Deviations

Shiseido America Inc. is recalling Shiseido Future Solutions LX Triple Points Bonus because the manufacturing of the active pharmaceutical ingredient did not meet GMP and quality requirements.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically involves a temporary or medically reversible adverse health consequence. The source cites GMP deviations regarding API manufacturing without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Shiseido America Inc. is recalling Shiseido Future Solutions LX Triple Points Bonus, a product containing SPF 50+ (octinoxate 4.9%, octocrylene 3.0%, oxybenzone 1.0%, and zinc oxide 15.4%) packaged in 15 mL tubes. The product is identified by NDC 58411-256-60 and SKU 95284.

The recall was initiated because the manufacturing of the active pharmaceutical ingredient (API) material did not meet Good Manufacturing Practice (GMP) and quality requirements. The product was distributed nationwide.

Consumers who have this product should stop using it and contact Shiseido America Inc. for further instructions or a refund.

The recalled product

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
Manufacturer
SHISEIDO AMERICA INC.
Category
Drug — Topical 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#: 95284

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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