The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0163-2023·Announced 2023-01-25

Hand Sanitizer Recalled for Manufacturing Practice Deviations

Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.

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 voluntary precautionary recall for manufacturing practice deviations. The source does not report illnesses or injuries, and the hazard is regulatory non-compliance rather than a direct product safety defect.

Plain-English summary

Fisher Scientific Co., LLC is voluntarily recalling HSANI500ML hand sanitizer containing 75% isopropyl alcohol. The recall affects 1,077 individual 500 mL bottles and 52 cases (6 bottles per case), distributed nationwide.

The recall is due to manufacturing practice deviations. The affected products were produced under temporary FDA approval that was set to expire on March 31, 2022. Per FDA guidance, products produced under this temporary approval should not be placed on the market after that date.

Consumers with affected products should discontinue use. Contact Fisher Scientific Co., LLC for instructions on return or replacement.

The recalled product

Product
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, 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
Hazard

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 Numbers: 202160
  • 202162
  • 202324
  • 202368
  • 202369
  • 202593
  • 202594
  • 202835
  • 202862
  • 202863
  • 202865
  • 202836
  • 202864
  • 203061
  • 203098
  • 203099
  • 203100
  • 203101
  • 203102
  • 203236

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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