The Recall Desk
ModerateFDA (Drugs)·D-0640-2024·Announced 2024-08-28

HAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation

HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.

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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard—a manufacturing process deviation involving water quality in production—is potential rather than realized. Per the rubric, recalls with no reported health outcomes and theoretical hazards score as Moderate.

Plain-English summary

HAND-I-SAN No-Rinse Hand Sanitizer (75% Isopropyl Alcohol) is being recalled nationwide and in Toronto, Canada due to manufacturing process deviations. The manufacturer, Zeco LLC, did not use sterile water in the production of this product, which violates Current Good Manufacturing Practices (CGMP) requirements.

The product was distributed in multiple sizes: 1-gallon jugs (cases of 4), 5-gallon pails, 55-gallon drums, and 275-gallon totes. Affected lots span from those expiring in July 2024 through May 2026, with specific lot numbers and expiration dates identified by the FDA.

Consumers who have purchased HAND-I-SAN should discontinue use. Those with specific lot numbers matching the recall should return the product or contact the manufacturer for instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 374
Manufacturer
Zeco LLC
Category
Drug — Hand Sanitizer
Hazard
  • cgmp-deviation
  • contamination

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 (20)

  • Lot #: a) 41320
  • Exp. Date 7/27/2024
  • 41020
  • Exp. Date 8/9/2024
  • BC06614
  • Exp. Date 8/15/2024
  • BCT07768
  • Exp. Date 9/23/2024
  • BCT09410
  • Exp. Date 11/17/2024
  • CCT02139
  • Exp. Date 3/10/2025
  • CCT01561
  • Exp. Date 3/15/2025
  • CCT02953
  • Exp. Date 4/10/2025
  • CCT02346
  • Exp. Date 4/21/2025
  • CCT03654
  • Exp. Date 5/11/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category