The Recall Desk
HighFDA (Drugs)·D-0104-2024·Announced 2023-11-22

DOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico

Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for hand sanitizer with non-compliant potency. No illnesses or injuries reported, but potency defects in a sanitizing product constitute a risk-of-harm product, justifying High severity.

Plain-English summary

Omega & Delta Co., Inc. is recalling DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8 FL OZ (237 mL) bottles. Approximately 23,136 bottles are affected by this recall.

An impact assessment identified that certain lot numbers did not comply with established finished product acceptance criteria for potency. The affected lot numbers are: 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, and 0245096.

The recalled product was distributed in Puerto Rico only. This is an FDA Class II recall.

The recalled product

Product
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
Manufacturer
Omega & Delta Co., Inc.
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 (8)

  • Lot #s 1113005
  • 1116005
  • 0237088
  • 0232084
  • 012764
  • 012864
  • 0244096
  • 0245096.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Omega & Delta Co., Inc. 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 3 products in this recall →

Related recalls

Same manufacturer · Omega & Delta Co., Inc.

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Same hazard · potency defect

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