CLASS II Drug recall · Reported 5 Jun 2019 · FDA Enforcement Report
Aquacil instant foaming hand sanitizer recalled by Inopak
Inopak is recalling Aquacil instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1%, distributed nationwide in the US. The recall was initiated on 22 Apr 2019 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-1311-2019
- FDA event ID
- 82645
- Recalling firm
- Inopak, Ringwood, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2019
- FDA classified
- 29 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 22 Apr 2019 | Recall initiated by company | |
| 29 May 2019 | Classified by FDA | +37 days |
| 5 Jun 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Product as listed by the FDA
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which lots are affected?
Batch #: 6736, 6826
Where was it sold?
Nationwide in the USA
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 products in this recall event
9 other products · FDA event 82645This product is part of a recall event; the main page for the event is Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X recalled by Inopak.
More recalls from Inopak
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Antibacterial Foaming Hand Wash With Moisturizers labeled recalled | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol recalled | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Instant Waterless Hand Sanitizer, Ethyl Alcohol recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Antibacterial Hand Soap, Healthcare recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Inoderm Antiseptic Hand Soap (E-2), .6% recalled by Inopak | Inopak | Manufacturing (CGMP) Deviations | Nationwide |