Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0357-2024·Announced 2024-03-06

Hand Sanitizer Recalled Nationwide for Manufacturing Practice Deficiencies

Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer due to manufacturing practice deviations identified during FDA inspection. The recall affects products distributed nationwide in the US and Puerto Rico.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is manufacturing-process-based rather than contamination or mislabeling with known pathogens. Per the rubric, when no harm is reported and the hazard is theoretical, the score does not exceed 3. This manufacturing deficiency without documented impact scores as Moderate.

Plain-English summary

Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer, an all-in-one foaming hand sanitizer and cleanser product.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. During an FDA inspection of Seatex's manufacturing facility, deficiencies were identified in the manufacturing controls and processes.

The recall affects 274 cases distributed nationwide in the United States and Puerto Rico. The affected lots are Lot #265029 (expiration date 03/27/2024) and Lot #273759 (expiration date 11/29/2024). The product was manufactured by Seatex LLC, located at 445 TX Hwy 36, Rosenberg, TX 77471.

Consumers who have purchased affected lots should discontinue use and contact the manufacturer or their retailer for instructions on product return or disposal.

The recalled product

Product: PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
Manufacturer: Seatex LLC
Category: Drug — Hand Sanitizer
Hazard: cgmp-deviation
manufacturing-deficiency
Affected units: 274

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 (4)

Lot #: 265029
Exp. 03/27/2024
273759
Exp. 11/29/2024.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Seatex LLC 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 · Seatex LLC

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Same hazard · cgmp deviation