Recall Z-0396-2026
Daye (Anne's Day Ltd) · initiated February 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Codes / lots: Model Number: FG-BNDL-PC-MM-REFAIO; UDI-DI: 5060994741605; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165, CS002165NS001653, CS002166, CS002166NS001648ST23/M/3001-0223ADL, CS002167, CS002168, CS002169, CS002177, CS002181, CS002183, CS002195, CS002196, CS003005, CS003015, CS003016, CS003022, CS003034, CS003048, CS003049, CS003050, CS003052, CS003053, CS003054, CS003055, CS003057, CS003062, CS003081, CR001615, CR001616CS002163NR001890NS001649, CR001616CS002163NR001892NS001650, CR001616CS002164, CR001617CS002165, CR001655CS002196, CS002163, CS002164, CR001661NR002015, CS003005NS001775…
Reason for recall
Product lacks 510(k) clearance.
FDA-determined cause: No Marketing Application
Action taken
On February 17, 2025 emails were sent to customers. In light of this pause, we will unfortunately need to cancel your CBD tampon subscription at this time. We understand how disappointing this news may be, and we want you to know how much we appreciate your understanding and loyalty. As a token of our gratitude, we are giving you a $20 credit which will be automatically applied to your next order. You 1II see this reflected in your total when you proceed to checkout. This credit con be used for any product on our website, including our Nude Organic Tampons, which are made with the same commitment to quality and safety you trust from Daye. We know this product has been important to many of you, and we don't want to leave you without support. Our customer core team is here to help you explore alternative options and answer any questions you may have during this transition. You can reach us by email at hello@yourdaye.com.
Details
- Recall number
- Z-0396-2026
- Initiated
- February 17, 2025
- Posted by FDA
- October 28, 2025
- Product code
- HEB – Tampon, Menstrual, Unscented
- Quantity
- 3074 packs
- Distribution
- US Nationwide distribution.
- Recalling firm
- Daye (Anne's Day Ltd), London
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0379-2026 Class II | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0380-2026 Class II | 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0381-2026 Class II | 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0382-2026 Class II | 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0383-2026 Class II | 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0384-2026 Class II | 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0385-2026 Class II | 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0386-2026 Class II | Trial Tampon Box; Model Number: FG-TMP-REF04050504;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0387-2026 Class II | All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0388-2026 Class II | Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0389-2026 Class II | Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0390-2026 Class II | Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0391-2026 Class II | Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0392-2026 Class II | Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0393-2026 Class II | Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0394-2026 Class II | Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0395-2026 Class II | Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0397-2026 Class II | Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0398-2026 Class II | Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0399-2026 Class II | Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0400-2026 Class II | Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0401-2026 Class II | Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number:…Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0402-2026 Class II | Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number:…Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0403-2026 Class II | Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0404-2026 Class II | Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0405-2026 Class II | Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0406-2026 Class II | Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |
| Z-0407-2026 Class II | Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;Product lacks 510(k) clearance. | 02/17/2025Open, Classified |