Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0214-2018·Announced 2018-01-24

Shiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations

Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion because the manufacturing of active pharmaceutical ingredients 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 corresponds to a moderate severity score of 2, as the hazard involves GMP deviations without reported illnesses or injuries.

Plain-English summary

Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottles. The recall involves 248,661 bottles and tubes distributed nationwide. The product is identified by SKU number BE8047201 and NDC 98132-761-01.

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 is a Class II recall, 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.

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund. The source text does not specify a specific return address or customer service phone number, so consumers should refer to the official FDA recall notice for detailed contact information.

The recalled product

Product: bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
Manufacturer: SHISEIDO AMERICA INC.
Category: Drug — Sunscreen
Hazard: gmp-deviation
Affected units: 248,661

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#: BE8047201

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 →

Same manufacturer · SHISEIDO AMERICA INC.

See all →

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Shiseido Eye and Lip Collection Recalled for GMP Deviations
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Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations
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Same hazard · gmp deviation