Recall archive / FDA drug enforcement
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corpo... — FDA record D-1357-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
- Reason
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Classification
- Class II
- Recalling firm
- Aire-Master of America Inc
- Quantity
- 4,632 cartons
- Agency-reported status
- Terminated
- Source record identifier
- D-1357-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Florida, Illinois, Iowa, New Jersey
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 24, 2022
- Recall initiation date
- Jul 15, 2022
- Center classification date
- Aug 18, 2022
- Termination date
- Feb 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.