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.
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 3/5 (High).
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
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
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.
See all →- HighDOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico
FDA (Drugs) · 2023-11-22
- HighDOP Instant Hand Sanitizer Recalled for Potency Compliance Failures
FDA (Drugs) · 2023-11-22
Same hazard · sub potent
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