The Recall Desk
HighFDA (Drugs)·D-0105-2024·Announced 2023-11-22

Equate Hand Sanitizer recalled for potency non-compliance in Puerto Rico

Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.

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 with no reported illnesses or injuries. Potency non-compliance represents a risk-of-harm scenario where actual injury has not yet been reported, qualifying as High severity per the rubric.

Plain-English summary

Omega & Delta Co., Inc. is recalling 4,848 bottles of Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL), Lot #006511, because the product did not comply with established potency acceptance criteria.

During an impact assessment of the product, the manufacturer identified that the recalled lot was both sub-potent and super-potent.

The product was distributed in Puerto Rico. Consumers who have obtained this product should discontinue use and contact the manufacturer for guidance.

The recalled product

Product
Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Manufacturer
Omega & Delta Co., Inc.
Category
Drug — Hand Sanitizer
Hazard
  • sub-potent
  • super-potent

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 (1)

  • Lot #s 006511

Distribution

Distribution scope not specified by the agency.

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