The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0356-2024·Announced 2024-03-06

FDA Recalls PROBLEND Hand Sanitizer for Manufacturing Deviations

Seatex LLC is recalling 1,450 cases of PROBLEND Antibacterial Foaming Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations discovered at its manufacturing facility. The recall affects product distributed nationwide in the United States 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: This is an FDA Class II recall without reported illnesses, injuries, or hospitalizations. Per the severity rubric, Class II recalls without reported harm match the criterion for voluntary precautionary recalls, scoring 2 (Moderate).

Plain-English summary

Seatex LLC is recalling PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser (Benzalkonium Chloride 0.13%) due to manufacturing deviations identified during an FDA inspection. The recall affects 1,450 cases distributed nationwide in the United States and Puerto Rico.

The recalled product is available in two sizes: 1250 mL cases and 1 G cases with mountain spring scent. Affected lot numbers include 263647 (Exp. 06/09/2024), 271382 (Exp. 01/18/2025), 261675 (Exp. 04/09/2024), and 272766 (Exp. 02/15/2025).

The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Seatex's manufacturing facility located at 445 TX Hwy 36, Rosenberg, Texas. No illnesses or injuries have been reported in connection with this recall.

Consumers with questions about the recall or this product should contact Seatex LLC at the address listed above.

The recalled product

Product
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
Manufacturer
Seatex LLC
Category
Drug — Topical / Hand Sanitizer
Hazard
Affected units
1,450

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 (9)

  • Lot #s: a) 263647
  • Exp. 06/09/2024
  • 271382
  • Exp. 01/18/2025
  • b) 261675
  • Exp. 04/09/2024
  • 263647
  • 272766
  • Exp.02/15/2025.

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 →

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