CLASS II ONGOING Drug recall · Reported 10 May 2023 · FDA Enforcement Report
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer recalled
Seatex is recalling Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents, distributed in Florida, Georgia, Texas. The recall was initiated on 19 Apr 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-0562-2023
- FDA event ID
- 92164
- Recalling firm
- Seatex, Rosenberg, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Apr 2023
- FDA classified
- 3 May 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Apr 2023 | Recall initiated by company | |
| 3 May 2023 | Classified by FDA | +14 days |
| 10 May 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
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
Where it was distributed
FL, GA, TX
Questions about this recall
Why was it recalled?
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Which lots are affected?
Lot: 220888, Exp. 05/20/2023
Where was it sold?
FL, GA, TX
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.
More recalls from Seatex
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 7 Eleven For Gas Island Use Only, Hand Sanitizer recalled by Seatex | Seatex | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Problend Antibacterial Foaming Silk All-In-One Foaming Hand recalled | Seatex | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic recalled | Seatex | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Problend Hand Sanitizer, Refreshing Gel Hand Sanitizer recalled | Seatex | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Problend E3 Foaming Hand Sanitizer recalled by Seatex | Seatex | Manufacturing (CGMP) Deviations | Nationwide |