Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content
Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.
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 recall with no reported illnesses or injuries. The hazard is subpotency (below-label active ingredient concentration), which is a product-efficacy issue rather than a direct safety threat. Per the rubric, labeling and formulation defects without reported harm are typically Moderate (score 2).
Plain-English summary
Spectrum Advanced Gel Hand Sanitizer, 8 FL OZ (236 mL) bottles with 70% ethyl alcohol, manufactured for Medline Industries, Inc., is being recalled nationwide. The product is made by Consumer Product Partners, LLC.
The recall was issued because the product has a cloudy appearance and tested below the assay label claim for 70% ethyl alcohol. This means affected bottles contain less active ingredient than stated on the label, reducing their effectiveness as a hand sanitizer.
The affected lots are Lot 0644682 (expiration 2026/11/14) and Lot 0644683 (expiration 2026/11/16). A total of 125,040 bottles were distributed nationwide. The product NDC is 53329-202-08.
Consumers who have purchased this product should stop using it and contact the manufacturer with questions about replacement or refund options.
The recalled product
- Product
- HAND SANITIZER (ETHYL ALCOHOL)
- Brand
- HAND SANITIZER
- Manufacturer
- Consumer Product Partners, LLC
- Category
- Drug — Over-the-Counter Topical
- Affected units
- 125,040
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 (5)
- Lot
- expiry: Lot 0644682
- exp 2026/11/14
- Lot 0644683
- exp 2026/11/16
UPCs (2)
- 0193489179739
- 888277349455
Distribution
Distributed nationwide across the United States.
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