Recall archive / FDA device enforcement
ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 — FDA record Z-0268-2024
Reported ongoing
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 Oct 4, 2023. 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
- ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
- Reason
- Products were stored outside of labeled temperature requirements.
- Classification
- Class II
- Recalling firm
- Family Dollar Stores, Llc.
- Quantity
- 329,044 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0268-2024
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 | All units sold at stores between June 1, 2023 and October 4, 2023. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
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
- Nov 15, 2023
- Recall initiation date
- Oct 4, 2023
- Center classification date
- Nov 7, 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.