The Recall Desk
ModerateFDA (Drugs)·D-0164-2023·Announced 2023-01-25

Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.

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: Voluntary precautionary recall with no reported illnesses or injuries. Driven by regulatory non-compliance (expired temporary approval) and manufacturing practice deviations; classified FDA Class II but lacking reported harm indicators required for higher severity.

Plain-English summary

Fisher Scientific Co., LLC is voluntarily recalling HSANI4LI hand sanitizer, a 75% isopropyl alcohol solution packaged in 4-liter bottles. The recall affects 106 bottles distributed nationwide in the United States.

The recall is due to current Good Manufacturing Practice (CGMP) deviations. The FDA issued guidance requiring manufacturers to cease distributing hand sanitizer products produced under temporary pandemic emergency approval after March 31, 2022. All affected bottles were distributed after this regulatory deadline.

The recalled product includes lot numbers 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722, 203723, 203724, 203725, and 204852. Consumers and organizations that have received this product should discontinue use and contact Fisher Scientific for return instructions or proper disposal.

The recalled product

Product
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Manufacturer
Fisher Scientific Co., LLC
Category
Drug — Hand Sanitizer / Topical
Hazard
Affected units
106

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 (12)

  • Lot Numbers: 202161
  • 202322
  • 202323
  • 202794
  • 202858
  • 203188
  • 203238
  • 203240
  • 203722 203723
  • 203724
  • 203725
  • 204852

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Fisher Scientific Co., 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 2 products in this recall →

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