CLASS II Drug recall · Reported 6 Feb 2013 · FDA Enforcement Report
Hillyard, Alcohol Free Foaming Instant Hand Sanitizer recalled
Hillyard GMP is recalling Hillyard, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, distributed nationwide in the US. The recall was initiated on 28 Dec 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-140-2013
- FDA event ID
- 64020
- Recalling firm
- Hillyard GMP, Saint Joseph, MO
- Manufacturer
- Hillyard GMP
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2012
- FDA classified
- 31 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Hand Sanitizer
Timeline
| 28 Dec 2012 | Recall initiated by company | |
| 31 Jan 2013 | Classified by FDA | +34 days |
| 6 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Where it was distributed
Distribution nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Which lots are affected?
Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14
Where was it sold?
Distribution nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Benzalkonium Chloride recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Medi-First Antiseptic Wipes recalled by Acme UnitedMedi-first Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |