S.C. Johnson Recalls Alcohol-Free Foaming Hand Sanitizer Due to CGMP Deviations
S.C. Johnson Professional is recalling 258 cases of Alcohol Free Foaming Hand Sanitizer because the product was released to market prior to microbiological testing.
What this means for you
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: The recall is classified as FDA Class II, which typically indicates a reasonable probability that use may cause temporary or medically reversible health consequences. The hazard is a procedural CGMP deviation (release before testing) rather than a confirmed contamination or injury, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
S.C. Johnson Professional is recalling 258 cases of Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridges. The product is packaged in 8 cartridges per case and was distributed by Safe-T-Fresh Inc. in Minneapolis, MN. The specific lot number is 9085.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was released to the market before it had completed required microbiological testing. This procedural error means the safety and sterility of the product were not verified prior to distribution.
Consumers who have purchased this specific lot of hand sanitizer should stop using it and contact S.C. Johnson Professional for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
- Manufacturer
- S.C. Johnson Professional
- Category
- Drug — Topical Antiseptic
- Affected units
- 258
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 9085
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by S.C. Johnson Professional 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 →Related recalls
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