CLASS II ONGOING Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution recalled
Fisher Scientific Co is recalling Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, distributed nationwide in the US. The recall was initiated on 17 Jan 2023 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-0164-2023
- FDA event ID
- 91427
- Recalling firm
- Fisher Scientific Co, Fair Lawn, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jan 2023
- FDA classified
- 18 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Jan 2023 | Recall initiated by company | |
| 18 Jan 2023 | Classified by FDA | +1 day |
| 25 Jan 2023 | 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: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Product as listed by the FDA
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution recalled?
Yes. Fisher Scientific Co recalled Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution on 17 Jan 2023. The recall is Class II and its status is Ongoing. Recall number D-0164-2023.
Why was it recalled?
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Which lots are affected?
Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fisher Scientific Co
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v recalled | Fisher Scientific Co | Manufacturing (CGMP) Deviations | Nationwide |