Shiseido Eye and Lip Collection Recalled for GMP Deviations
Shiseido America Inc. is recalling the Future Solution LX Luxurious Eye & Lip Collection 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 manufacturing quality rather than a direct acute health threat like a high-risk pathogen, it fits the Moderate category for a voluntary precautionary recall.
Plain-English summary
Shiseido America Inc. is recalling the Shiseido Future Solution LX Luxurious Eye & Lip Collection, which contains SPF 50+ and is packaged in 15 mL tubes. The product is identified by SKU number 95393 and was distributed nationwide.
The recall was initiated because the manufacturing of the active pharmaceutical ingredient (API) material did not meet Good Manufacturing Practice (GMP) and quality requirements. This classification is designated as Class II by the U.S. Food and Drug Administration.
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 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
- Manufacturer
- SHISEIDO AMERICA INC.
- Category
- Drug — Cosmetic with SPF
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#: 95393
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.
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