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.
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, 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
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 →Related recalls
Same manufacturer · SHISEIDO AMERICA INC.
See all →- ModerateShiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations
FDA (Drugs) · 2018-01-24
- ModerateShiseido Sunscreen Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-01-24
- ModerateShiseido Eye and Lip Collection Recalled for GMP Deviations
FDA (Drugs) · 2018-01-24
- ModerateShiseido Future Solution LX Discovery Set Recalled for GMP Deviations
FDA (Drugs) · 2018-01-24
Same hazard · gmp deviation
See all →- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride further lots recalled over nitrosamine impurity levels
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- ModerateFirst Aid Only hand sanitizing wipes recalled over manufacturing deviations
FDA (Drugs) · 2026-03-11
- ModerateFirst Aid Only BZK antiseptic towelettes recalled over manufacturing deviations
FDA (Drugs) · 2026-03-11