The Recall Desk
ModerateFDA (Drugs)·D-0215-2018·Announced 2018-01-24

Shiseido Sunscreen Recalled for Manufacturing Quality Deviations

Shiseido America Inc. is recalling Future Solution LX Universal Defense SPF 50+ sunscreen because the manufacturing of active ingredient material 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. Per the rubric, this falls under 'voluntary precautionary recalls' or minor quality issues where no specific illness or injury is reported, aligning with a Moderate severity score.

Plain-English summary

Shiseido America Inc. is recalling Shiseido Future Solution LX Universal Defense SPF 50+ sunscreen. The product is available in 2 mL, 15 mL, and 50 mL tubes and contains octinoxate, octocrylene, oxybenzone, and zinc oxide. The recall is due to GMP deviations where the manufacturing of the active pharmaceutical ingredient (API) material did not meet Good Manufacturing Practice and quality requirements.

The product was distributed nationwide. Specific lot numbers are not provided in the source text, but the recall includes products with the following SKUs: 8C52541, 8B41841, 1155840, 1155841, 1155842, 1155851, 0710341, and 0710342. The NDC for the product is 58411-256-60.

Consumers who have this product should stop using it and contact Shiseido America Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Shiseido 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
Manufacturer
SHISEIDO AMERICA INC.
Category
Drug — 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 (8)

  • SKU#: a) 8C52541
  • b) 8B41841
  • c) 1155840
  • 1155841
  • 1155842
  • 1155851
  • 0710341
  • 0710342

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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