Isopropyl hand sanitizer recalled because methanol risk could not be excluded
Acuity Specialty Products is recalling AFCO isopropyl alcohol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.
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: Scored 3 under the risk-of-harm criterion: untested alcohol leaves methanol contamination unexcluded, a hazard for which no injury has been reported.
Plain-English summary
AFCO Hand Sanitizer (isopropyl alcohol-based, Product 5515), manufactured by AFCO of Chambersburg, Pennsylvania, is being recalled for cGMP deviations. The product was supplied in 4x1 gallon cases, 5 gallon pails and 55 gallon drums.
The recall was initiated because required receipt testing of the incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
The recall covers lots C2432725 (expiring 22 November 2025), C2508304 (expiring 24 March 2026) and C2509304 (expiring 3 April 2026), distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record describes an unverified raw material rather than confirmed methanol, and reports no injuries. Anyone holding the listed lots should stop using them and follow the firm's instructions.
The recalled product
- Product
- AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
- Manufacturer
- Acuity Specialty Products, Inc.
- Category
- Drug — Hand sanitizer
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 (6)
- Lot # C2432725
- Exp 11/22/2025
- Lot # C2508304
- Exp 3/24/2026
- Lot # C2509304
- Exp 4/3/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Acuity Specialty Products, 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 2 products in this recall →Related recalls
Same manufacturer · Acuity Specialty Products, Inc.
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